Safety Report Updates

Listed below are the products that have had a report on adverse events presented to the Pediatric Advisory Committee(PAC). Click on the drug name to go to the meeting materials. Each column is sortable by the arrow. The table is searchable by keyword (e.g., drug name, PAC date, or recommendation(s)).

Product	Pediatric Labeling Change or Exclusivity Granted* Date	Type of Presentation	Presentation Date	Pediatric Advisory Committee Recommendations and Subsequent Outcomes
Flourish Pediatric Esophageal Atresia Device	5/12/2017	Meeting	9/17/2021	The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2022.
Intelence (etravirine)	2/27/2013	Meeting	9/16/2015	September 16, 2015 – Committee members agreed to the FDA plan to continue ongoing safety monitoring.
Intelence (etravirine)	3/26/2012	Meeting	4/21/2014	April 21, 2014 - PAC recommended return to standard, ongoing monitoring for adverse events.
Vyvanse	1/28/2017	Meeting	9/15/2020	The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Mydayis	6/20/2017	Meeting	9/15/2020	The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Orencia	3/30/2017	Meeting	9/15/2020	The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Adzenys ER	9/15/2017	Meeting	9/15/2020	The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Flourish Pediatric Esophageal Atresia Device	5/12/2017	Meeting	9/15/2020	The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
Gamunex-C	12/4/2015	Meeting	9/15/2020	The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Medtronic Activa® Dystonia Therapy, mandated annual review	1/16/2013	Web	9/2/2020	September 2, 2020 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
AFSTYLA (antihemophilic factor [recombinant], single chain)	5/25/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Butrans (buprenorphine transdermal system)	10/13/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing surveillance
Draximage DTPA (technetium TC-99m pentetate kit) injection and inhalation	12/26/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Dysport (AbobotulinumtoxinA)	7/29/2016	Web	9/2/2020	September 2, 2020- FDA will continue post-marketing safety surveillance.
Epicel (cultured epidermal autografts)	2/18/2016	Web	9/2/2020	September 2, 2020- FDA will continue post-marketing safety surveillance.
KOVALTRY (antihemophilic factor [recombinant])	3/16/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Liposorber® LA-15 System mandated annual review	10/10/2013	Web	9/2/2020	September 2, 2020 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
Lumason (sulfur hexafluoride lipid-type A microspheres) injectable suspension	3/31/2016 and 12/22/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Omidria (Phenylephrine and ketorolac intraocular solution)	12/8/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Stelara (ustekinumab) injection	10/13/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Symfi Lo™ (efavirenz 400mg + lamivudine 300mg + tenofovir disoproxil fumarate 300mg)	2/5/2018	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Symfi™ (efavirenz 600mg + lamivudine 300mg + tenofovir disoproxil fumarate 300mg)	3/22/2018	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Canasa (mesalamine suppositories for rectal use)	9/2/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Contegra Pulmonary Valved Conduit (HDE), mandated annual review	4/11/2013	Web	9/2/2020	September 2, 2020 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
Descovy® (emtricitabine and tenofovir alafenamide)	9/28/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Elana Surgical Kit (HDE), mandated annual review	3/10/2011	Web	9/2/2020	September 2, 2020 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
Enterra Therapy System (HDE ), mandated annual review	3/25/2013	Web	9/2/2020	September 2, 2020 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
Flucelvax (influenza vaccine)	5/23/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Flucelvax Quadrivalent (influenza vaccine)	5/23/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
FluLaval (influenza vaccine)	11/18/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
FluLaval Quadrivalent (influenza vaccine)	11/18/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir)	9/25/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]	1/14/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted	9/9/2016	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Lumify (brimonidine tartrate) OTC	12/22/2017	Web	9/15/2020	September 15, 2020 - FDA will continue post-marketing safety surveillance.
Luzu (luliconazole) cream, 1%	2/20/2018	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Pleximmune™ in-vitro diagnostic test (HDE), mandated annual review	8/26/2014	Web	9/2/2020	September 2, 2020 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
PulseRider Aneurysm Neck Reconstruction Device (HDE) mandated annual review	6/19/2017	Web	9/2/2020	September 2, 2020 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2021.
Sensipar (cinacalcet)	5/23/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Triumeq (abacavir, dolutegravir, and lamivudine)	11/21/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Xepi (ozenoxacin)	12/11/2017	Web	9/2/2020	September 2, 2020 - FDA will continue post-marketing safety surveillance.
Ativan injection (lorazepam)	5/27/2016	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Calcium gluconate injection (calcium gluconate)	6/15/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Cerebyx® (fosphenytoin sodium)	3/1/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Contegra Pulmonary Valved Conduit, (HDE) mandated annual review	4/11/2013	Web	9/26/2019	September 26, 2019 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
Dotarem (gadoterate meglumine)	8/25/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Elana Surgical Kit (HDE), mandated annual review	3/10/2011	Web	9/23/2019	September 23, 2019 - FDA reported that there was no reported use, or new publications in the last year. The post approval study has been put on hold due to non-use in the United States, and would resume if there are any reported sales and use. The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
Enterra Therapy System (HDE), mandated annual review	3/25/2013	Web	9/23/2019	September 23, 2019 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
E-Z-HD (barium sulfate)	1/11/2016	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Fycompa (perampanel) oral tablets and suspension	6/19/2015, 4/29/2016, 7/26/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Gammaplex - Immune Globulin Intravenous (Human) 5% Liquid	7/30/2015	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Harvoni (ledipasvir and sofosbuvir )	4/7/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Isentress and Isentress HD (raltegravir )	5/26/2017 & 11/22/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Latuda (lurasidone hydrochloride)	1/27/2017 & 03/05/2018	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Liquid E-Z-Paque (barium sulfate)	3/1/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Nuwiq (simoctocog alfa)	9/4/2015	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Pleximmune™ in-vitro diagnostic test (HDE), mandated annual review	8/26/2014	Web	9/23/2019	September 23, 2019 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
PulseRider Aneurysm Neck Reconstruction Device(HDE), mandated annual review	6/19/2017	Web	9/23/2019	September 23, 2019 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
Rapivab® (peramivir)	9/20/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Readi-Cat 2, Readi-Cat 2 smoothies (barium sulfate)	1/15/2016	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Ryzodeg 70/30 (insulin degludec 70 units/ml and insulin aspart 30 units/ml FlexTouch Pen)	12/16/2016	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Simponi (golimumab SC)	6/22/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Sovaldi (sofosbuvir)	4/7/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)	1/27/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
TACHOSIL (Fibrin Sealant Patch)	7/15/2015	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Tresiba (insulin degludec injection) U-100 and U-200 FlexTouch Pans and U-100 multidose vial	12/16/2016	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Varibar pudding (barium sulfate)	10/14/2016	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%)	3/14/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Visipaque (iodixanol) injection	4/5/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
WILATE (von Willebrand Factor/ Coagulation Factor VIII Complex (Human))	8/5/2015	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Zemplar (paricalcitol)	10/18/2016	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Zymar® (gatifloxacin ophthalmic solution 0.3%)	3/21/2017	Web	9/23/2019	FDA will continue post-marketing safety surveillance.
Oxycontin extended release tablets	8/13/2015	Meeting	9/26/2019	September 26, 2019 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Aczone (dapsone) gel, 7.5%	2/24/2016	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Adynovate	1/13/2015	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
AirDuo RespiClick (fluticasone propionate and salmeterol xinafoate) ArmonAir RespiClick (fluticasone propionate)	1/27/2017	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Avelox (moxifloxacin, tablets and injection)	9/27/2016	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Caldolor (ibuprofen) IV injection	11/20/2015	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Cubicin® and Cubicin® RF (daptomycin for injection)	3/29/2017	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Dexilant, Dexilant SoluTab (dexlansoprazole)	7/8/2016	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Epicel (cultured epidermal autografts), mandated annual review	10/25/2007	Web	3/28/2019	March 28, 2019 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
Eucrisa (crisaborole) ointment, 2%	12/14/2016	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Flourish™ Pediatric Esophageal Atresia Device, mandated annual review	5/12/2017	Web	3/28/2019	The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
IXINITY [Coagulation Factor IX (Recombinant)]	5/14/2015	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Liletta (levonorgestrel-releasing intrauterine system)	2/26/2015	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Liposorber® LA-15 System, mandated annual review	10/10/2013	Web	3/28/2019	March 28, 2019 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
Lyrica (pregabalin)	12/22/2016	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Medtronic Activa® Dystonia Therapy, mandated annual review	1/16/2013	Web	3/28/2019	March 28, 2019 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2020.
Narcan (naloxone) nasal spray	11/18/2015	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Ofirmev (acetaminophen) injection	1/27/2017	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Selzentry (maraviroc)	11/4/2016	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Spiriva Respimat (tiotropium bromide)	2/15/2017	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Symbicort (budesonide/ formoterol fumarate dihydrate)	1/27/2017	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Tarceva™ (erlotinib)	4/27/2015	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Velcade® (bortezomib)	9/14/2015	Web	3/28/2019	FDA will continue post-marketing safety surveillance.
Zoloft (sertraline)¹⁶	2/1/2002	Meeting	6/12/2003	June 12, 2003- Pediatric Subcommittee (PS) in conjunction with the Psychopharmacologic Drugs Advisory Committee (PDAC) requested re-analysis of Selective Serotonin Reuptake Inhibitor (SSRI) data once the cases are reclassified and for FDA to issue a warning in the interim on the potential side effects of the SSRIs. *February 3, 2004* - PS agreed to future update on SSRIs, neonatal withdrawal, and eye malformation; On March 22, 2004 - FDA issued a Public Health Advisory; Antidepressant Public Health Advisory June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome; *September 13, 2004* - PAC in conjunction with the PDAC Neuropsychiatry Committee after reviewing the re-analysis of pediatric cases suicidality, the committee voted for a MedGuide and "black box" warning to be applied to all antidepressants. *October 15, 2004* - FDA directs manufacturers of all antidepressant medications to add a "black box" warning and develop a patient medication guide (MedGuide). See templates for proposed changes labeling Antidepressant Public Health Advisory 10.15.2004 and MedGuide (historical information scroll down for MedGuide template).
Intuniv (guanfacine extended-release)	11/19/2014 and 3/18/2015	Meeting	9/20/2018	FDA will continue post-marketing safety surveillance.
Lexapro (escitalopram)	10/31/2014	Meeting	9/20/2018	FDA will continue post-marketing safety surveillance.
Bexsero (Meningococcal Group B Vaccine)	1/23/2015	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Contegra Pulmonary Valved Conduit (Humanitarian Device Exemption [HDE]), mandated annual review	4/11/2013	Web	9/12/2018	September 12, 2018 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2019.
Elana Surgical Kit (HDE), mandated annual review	3/10/2011	Web	9/12/2018	September 12, 2018 - FDA reported that there was no reported use, or new publications in the last year. The post approval study has been put on hold due to non-use in the United States, and would resume if there are any reported sales and use. The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2019.
Enterra Therapy System (HDE), mandated annual review	3/25/2013	Web	9/12/2018	September 12, 2018 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2019.
Entocort EC (budesonide)	4/29/2016	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Epzicom (abacavir sulfate and lamivudine) and Ziagen (abacavir sulfate)	9/17/2015 and 3/23/2015	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Kovanaze (tetracaine HCl and oxymetazoline HCl)	6/29/2016	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Lamictal (lamotrigine)	5/18/2015	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Oraverse (phentolamine mesylate)	3/18/2016	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Pancreaze & Pertzye (pancrelipase)	3/7/2014 and	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Pleximmune™ in-vitro diagnostic test (HDE), mandated annual review	8/26/2014	Web	9/12/2018	September 12, 2018 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2019.
PulseRider Aneurysm Neck Reconstruction Device (HDE), initial review	6/19/2017	Web	9/12/2018	September 12, 2018 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2019.
Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)	3/24/2015	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Renvela (sevelamer carbonate)	11/25/2016	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Zomig Nasal Spray (zolmitriptan)	6/12/2015	Web	9/12/2018	FDA will continue post-marketing safety surveillance.
Adzenys XR and Dyanavel XR (amphetamine)	9/15/2017 and 10/19/2015	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Anthim (obiltoxaximab)	3/18/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Aptensio XR and Quillichew (methylphenidate hydrochloride)	4/17/2015	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Cinqair (reslizumab)	3/23/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Cutivate (fluticasone propionate)	1/16/2015	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Descovy ® (emtricitabine and tenofovir alafenamide)	4/4/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Epivir (lamivudine)	3/23/2015	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Kaletra (lopinavir and ritonavir)	6/26/2015	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Natroba (spinosad)	12/30/2014	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Noxafil (posaconazole)	9/9/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Oraltag (iohexol)	3/26/2015	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Otovel Otic Solution (ciprofloxacin and fluocinolone acetonide)	4/29/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Prilosec (omeprazole)	2/3/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
ProAir RespiClick (abuterol sulfate)	4/28/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Procysbi (cysteamine bitartrate)	12/22/2017	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Teflaro Injection (ceftaroline fosamil)	5/27/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Tetracaine Hydrochloride Ophthalmic Solution (tetracaine hydrochloride)	2/29/2016	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Xopenex HFA Inhalation Aerosol (levalbuterol)	3/12/2015	Web	6/13/2018	FDA will continue post-marketing safety surveillance.
Banzel (rufinamide)	2/12/2015	Web	4/25/2018	FDA will continue post-marketing safety surveillance.
Liposorber® LA-15 System, mandated annual review	10/10/2013	Web	4/25/2018	April 25, 2018 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2019.
Medtronic Activa® Dystonia Therapy, mandated annual review	1/16/2013	Web	4/25/2018	April 25, 2018 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2019.
Atropine Sulfate Opthalmic Solution, UPS 1%	7/18/2014	Web	3/3/2018	FDA will continue post-marketing safety surveillance.
Emend (aprepitant) Capsule and Oral Suspension	8/28/2015	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Epicel (cultured epidermal autografts)	2/18/2016	Web	3/5/2018	March 5, 2018 - FDA will continue post-marketing safety surveillance.
Epiduo Forte (adapalene/benzoyl peroxide, 0.3%/2.5%) gel	7/15/2015	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Flourish Pediatric Esophageal Atresia Device	5/12/2017	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Gadavist (gadobutrol); Eovist or Primovist (gadoxetate disodium)	12/29/2014; 4/27/2016, 3/27/2015	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)	12/10/2014	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) oral tablets	11/5/2015	Web	3/5/2018	March 5, 2018 - FDA will continue post-marketing safety surveillance.
Kapvay (clonidine extended-release) tablets	11/20/2014& 8/16/2016	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Nucala (mepolizumab)	11/4/2015	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Saphris (asenapine)	3/12/2015	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Tivicay (dolutegravir)	8/12/2013 & 6/9/2016	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Trumenba Meningococcal Group B Vaccine	10/29/2014	Web	3/5/2018	FDA will continue post-marketing safety surveillance.
Dymista (azelastine hydrochloride fluticasone propionate)	2/20/2015	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
Edurant (rilpivirine); Complera; and Odefsey	8/26/2015; 2/23/2016; 3/1/2016	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
Merrem IV (meropenem)	12/19/2014	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
Naftin (nafifine hydrochloride)	10/10/2014 & 11/11/2016	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
OTIPRIO (ciprofloxacin otic suspension)	12/10/2015	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
PAZEO (olopatadine hydrochloride ophthalmic solution)	1/30/2015	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
QNASL beclomethasone dipropionate) nasal aerosol	12/17/2014	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
Treximet (naproxen sodium sumatriptan succinate)	5/14/2015	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
Valcyte (valganciclovir)	4/23/2015	Web	1/7/2018	FDA will continue post-marketing safety surveillance.
Keppra and Keppra XR (levetiracetam)	8/1/2014	Meeting	9/12/2017	September 12, 2017 - FDA did not identify any new safety signals, and plans to monitor for cardiovascular adverse events, rhabdomyolysis, and encephalopathy. The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Aloxi (palonosetron hydrochloride)	5/27/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Arnuity Ellipta (fluticasone furoate)	8/20/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Asmanex HFA and Asmanex Twisthaler (mometasone furoate inhalation)	4/25/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Cymbalta (duloxetine)	10/16/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Emsam (selegiline transdermal system)	9/10/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
GRASTEK® Safety Review GRASTEK® Utilization Review (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use	4/11/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Latisse® (bimatoprost ophthalmic solution) 0.03%	9/4/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Namenda and Namenda XR extended-release (memantine hydrochloride)	7/3/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
ORALAIR Safety Review ORALAIR Utilization Review (Sweet Vernal, Orchard Perennial rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for sublingual Use	4/1/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Priftin® (rifapentine)	11/25/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Reyataz® (atazanavir)	6/2/2014 & 9/24/2015	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Taclonex (betamethasone dipropionate/calcipotriene hydrate) 0.064%/0.005%	8/29/2014 & 12/23/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Zetonna (ciclesonide)	10/23/2014	Web	8/4/2017	FDA will continue post-marketing safety surveillance.
Abilify (aripiprazole)	6/9/2014	Meeting	9/12/2017	September 12, 2017 - The PAC discussed the limitations of adverse event data collected in regards to rates of suicidality, serious metabolic disorders, and weight gain. One PAC members noted that some pediatric patients with autism may not be able to communicated about suicidal ideation. The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Contegra Pulmonary Valved Conduit, mandated annual review	4/11/2013	Meeting	9/12/2017	September 12, 2017 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Enterra Therapy System (HDE), mandated annual review	3/25/2013	Meeting	9/12/2017	September 12, 2017 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Pleximmune™, in-vitro diagnostic test (HDE), mandated annual review	8/26/2014	Meeting	9/12/2017	September 12, 2017 - The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Elana Surgical Kit (HUD), mandated annual review	3/10/2011	Meeting	9/12/2017	September 12, 2017 - FDA reported that there was no reported use, or new publications in the last year. The post approval study has been put on hold due to non-use in the United States, and would resume if there are any reported sales and use. The Committee concurred with the FDA plan to continue device surveillance and report to the PAC in 2018.
Salonpas Relief (methyl salicylate 10% and 1-menthol 3%P Patch)	3/29/2013	Web	9/12/2016	FDA will continue post-marketing safety surveillance.
Nitropress (sodium nitroprusside)	11/22/2013	Meeting	3/6/2017	March 6, 2017- The Committee discussed the issue of elevated carboxyhemoglobin levels noted in some patients receiving Nitropress and voted that there was insufficient data available at this time to make a labeling change. The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Kuvan (sapropterin dihydrochloride)	4/23/2014	Meeting	3/7/2017	March 7, 2017- The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Novoeight® (turotocog alfa) Antihemophilic Factor (Recombinant)	10/15/2013	Meeting	3/7/2017	March 7, 2017- The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
RIXIBUS Coagulation Factor IX (Recombinant)	4/1/2014	Meeting	3/7/2017	March 7, 2017 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Medtronic Activa® Dystonia Therapy, mandated annual review	1/16/2013	Meeting	3/7/2017	March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Impella RP System, mandated annual review	1/23/2015	Meeting	3/7/2017	March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Liposorber® LA-15 System, mandated annual review	10/10/2013	Meeting	3/7/2017	March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Epicel (cultured epidermal autografts), initial review	10/25/2007	Meeting	3/7/2017	March 7, 2017- The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, and MDR review to the PAC in 2018.
Aleve PM® (naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg)	1/17/2014	Web	2/3/2017	FDA will continue post-marketing safety surveillance.
Astepro (azelastine hydrochloride)	8/30/2013 & 2/20/2015	Web	2/3/2017	FDA will continue post-marketing safety surveillance.
Jetrea® (ocriplasmin) Intravitreal Injection	6/13/2014	Web	2/3/2017	FDA will continue post-marketing safety surveillance.
Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol tablets, for oral use)	3/28/2013	Web	2/3/2017	FDA will continue post-marketing safety surveillance.
Spectazole (econazole nitrate) cream, 1% Ecoza (econazole nitrate) topical foam, 1%	10/24/2013	Web	2/3/2017	FDA will continue post-marketing safety surveillance.
Truvada® (emtricitabine and tenofovir disoproxil fumarate)	7/8/2011	Web	2/3/2017	FDA will continue post-marketing safety surveillance.
Xerese® (5% acyclovir and 1% hydrocortisone cream)	1/22/2014	Web	2/3/2017	FDA will continue post-marketing safety surveillance.
Lysteda (tranexamic acid)	8/21/2013	Web	9/12/2016	FDA will continue post-marketing safety surveillance.
Baraclude (entecavir)	3/20/2014	Web	9/12/2016	FDA will continue post-marketing safety surveillance.
Isentress (raltegravir potassium)	12/20/2013	Web	9/12/2016	FDA will continue post-marketing safety surveillance.
MENVEO (Meningococcal Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine)	8/1/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
IXIARO (Japanese Encephalitis Vaccine)	5/17/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Sustiva (efavirenz)	5/2/2013	Meeting	9/14/2016	September 14, 2016 - The Committee discussed the role of therapeutic drug levels, the risks to rapid metabolizers, how genomic testing would be useful, and the importance of adding this information to the label. The Committee welcomed a future discussion and review of these general issues. The Committee concurred with the FDA proposal to considering adding the term catatonia to labeling; voted against the FDA to return with drug levels and genetic variations in the labeling, and concurred with the FDA proposal to continue post-marketing safety surveillance.
Topamax (topiramate)	3/28/2014	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Asacol & Asacol HD (mesalamine)	10/8/2013 & 5/27/2015	Meeting	9/14/2016	September 14, 2016 - The Committee voted againstthe FDA recommendation to not change the label regarding benign intracranial hypertension. They requested that FDA further review this possible association, and concurred with the FDA recommendation to add nephrogenic diabetes insipidus to the list of adverse reactions that have been reported in the post -marketing section of product labeling for mesalamine products.
Delzicol (mesalamine)	4/28/2014 & 9/9/2015	Meeting	9/14/2016	September 14, 2016 - The Committee voted against the FDA recommendation to not change the label regarding benign intracranial hypertension. They requested that FDA further review this possible association, and concurred with the FDA recommendation to add nephrogenic diabetes insipidus to the list of adverse reactions that have been reported in the post -marketing section of product labeling for mesalamine products.
Kepivance (palifermin)	5/13/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Bloxiverz (neostigmine methylsufate)	5/31/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Doryx (doxycycline hyclate)	4/11/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Xolair (omalizumab)	3/21/2014	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Karbinal ER (carbinoxamine maleate)	3/23/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue post-marketing safety surveillance.
Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD), mandated annual review	2/16/2011	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Contegra Pulmonary Valved Conduit, mandated annual review	4/11/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Pleximmune™ in-vitro diagnostic test (HDE), mandated annual review	8/26/2014	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Enterra™ Therapy System, mandated annual review	3/25/2013	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Elana Surgical Kit (HUD), mandated annual review	3/10/2011	Meeting	9/14/2016	September 14, 2016 - The Committee concurred with the FDA proposal to continue surveillance and report the annual distribution number, literature review, MDR review to the PAC in 2017.
Ditropan (oxbutynin)	*2/28/2002	Meeting	11/16/2006	November 16, 2006 (review update for QT Prolongation with Celexa and Lexapro) - Recommend routine monitoring for AEs in all populations.
Ditropan (oxybutynin)¹⁷	*2/8/2002	Meeting	6/12/2003	June 12, 2003 - PS requested future review after additional marketing experience. November 16, 2006 - Preliminary reassessment. February 6, 2008 - revised label
Ditropan (oxybutynin)¹⁷	*2/8/2002	Meeting	4/11/2007	April 11, 2007 (Follow-up) - The PAC requested labeling to include additional information concerning post-marketing reports of hallucinations and agitated behavior in the pediatric population. They noted prescribers might wish to first try decreasing the dose before discontinuing, depending on the circumstances of the adverse event.
Lipitor (atorvastatin)¹⁸	*2/22/2002	Meeting	6/12/2003	June 12, 2003 - PS requested future review after additional marketing experience.
Lipitor (atorvastatin)¹⁸	*2/22/2002	Meeting	11/16/2006	November 16, 2006 (Follow-up) - Committee recommended return to routine monitoring for adverse events (AEs) in all populations.
Zocor (simvastatin)¹⁹	*2/22/2002	Meeting	6/12/2003	June 12, 2003 - PS requested future review after additional marketing experience.
Zocor (simvastatin)¹⁹	*2/22/2002	Meeting	11/16/2006	November 16, 2006 (Follow-up) - Pediatric Advisory Committee recommended return to routine monitoring for AEs in all populations.
Busulfex (busulfan)²⁰	*3/12/2002	Meeting	10/29/2003	October 29, 2003 - PS recommended return to routine monitoring for AEs in all populations.
Zyrtec (cetirizine)²¹	*3/13/2002	Meeting	10/29/2003	October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Cozaar (losartan)²²	*3/20/2002	Meeting	10/29/2003	October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Nolvadex (tamoxifen)²³	*5/16/2002	Meeting	10/29/2003	October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Accupril (quinapril)²⁴	*6/7/2002	Meeting	10/29/2003	October 29, 2003 - Committee recommended return to routine monitoring for AEs in all populations.
Serzone (nefazodone)²⁵	*6/27/2002	Meeting	10/29/2003	October 29, 2003 - For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl).
Paxil (paroxetine)²⁶	*6/27/2002	Meeting	2/3/2004	February 2, 2004 - For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl); February 3, 2004 - PS agreed to future update on SSRIs, neonatal withdrawal, and eye malformation; June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome.
Pravachol (pravastatin)²⁷	*7/10/2002	Meeting	2/3/2004	February 3, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Celexa (citalopram)²⁸	*7/12/2002	Meeting	2/3/2004	February 2, 2004 - For additional information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl); February 3, 2004 - PS agreed to future update on SSRIs, neonatal withdrawal, and eye malformation; PS requested update on QTc prolongation following future review of additional marketing experience; June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome; February 18, 200 - label revised
Celexa (citalopram)²⁸	*7/12/2002	Meeting	11/16/2006	November 16, 2006 (Follow-up) - PAC requested to receive/hear the results of the division's review of the company's QTc analysis, which they thought would be more useful than additional reviews of Adverse Events Reporting System (AERS).
Navelbine (vinorelbine)²⁹	*8/15/2002	Meeting	2/3/2004	February 3, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Hycamtin (topotecan)³⁰	*11/20/2002	Meeting	6/9/2004	June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Temodar (temozolomide)³¹	*11/20/2002	Meeting	6/9/2004	June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Effexor (venlafaxine)³²	*12/2/2002	Meeting	6/9/2004	February 2, 2004 - For information regarding PS recommendations and outcomes for SSRIs see Zoloft (sertraline HCl); June 9, 2004 - PS endorsed class labeling for neonatal toxicity/withdrawal syndrome. February 18, 2005 - label revised
Vigamox (moxifloxacin)³³	*1/10/2003	Meeting	6/9/2004	June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Ciloxan (ciprofloxacin)³⁴	*1/10/2003	Meeting	6/9/2004	June 9, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Monopril (fosinopril)³⁵	*1/27/2003	Meeting	6/9/2004	June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Allegra (fexofenadine)³⁶	*1/27/2003	Meeting	6/9/2004	June 9, 2004 - PS recommended return to routine monitoring for AEs in all populations.
Duragesic (fentanyl)³⁷	*1/29/2003	Meeting	6/9/2004	June 9, 2004 - PS strongly recommends that the "black box" section contain additional language indicating that: "inappropriate use may result in serious adverse effects including death" and highlight the need for qualifications of those prescribing the medication. Label updated February 2005, with black box warning and statement concerning use only in opioid tolerant patient. February 7, 2008 - Revised label38 View Duragesic MedGuide³⁹
Pulmicort/Rhinocort (budesonide)⁴⁰	*11/12/2002	Meeting	9/15/2004	September 15, 2004 - Committee agreed with the Division of Pulmonary and Allergy Drug Products proposed label changes and recommended that a MedGuide be provided for pediatric family caregivers with respect to the new labeling for Salmeterol and Advair label changes; July 20, 2006 - MedGuide approved
Clarinex (desloratadine)⁴¹	*2/12/2003	Meeting	9/15/2004	September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Cutivate/Flonase/Flovent (fluticasone),⁴² Advair (fluticasone and salmeterol)⁴³	*2/25/2003	Meeting	9/15/2004	September 15, 2004 - Committee recommendation that a MedGuide be provided for pediatric family caregivers with respect to the new labeling for Salmeterol and Advair label changes; March 2, 2006 - MedGuide approved
Ocuflox (ofloxacin)⁴⁴	*3/12/2003	Meeting	9/15/2004	September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Fludara (fludarabine)⁴⁵	*4/3/2003	Meeting	9/15/2004	September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Fosamax (alendronate)⁴⁶	*4/28/2003	Meeting	9/15/2004	September 15, 2004 - Committee recommended return to routine monitoring for AEs in all populations.
Lotensin (benazepril)⁴⁷	*7/2/2003	Meeting	2/14/2005	February 14, 2005 - Committee recommended continued close monitoring of benazepril in the pediatric population for future review.
Lotensin (benazepril)⁴⁷	*7/2/2003	Meeting	3/25/2008	March 25, 2008 (Follow-up) - Committee recommended return to routine monitoring for AEs in all population
Malarone (atovaquone/proguanil)⁴⁸	*8/6/2003	Meeting	2/14/2005	February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Brevibloc (esmolol)⁴⁹	*8/22/2003	Meeting	2/14/2005	February 14, 2005 - Committee recommended to continue monitoring and provide future review.
Brevibloc (esmolol)⁴⁹	*8/22/2003	Meeting	3/25/2008	March 25, 2008 (Follow-up) - Committee recommended return to routine monitoring for AEs in all populations.
Viracept (nelfinavir)⁵⁰	*9/4/2003	Meeting	2/14/2005	February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Xenical (orlistat)⁵¹	*9/12/2003	Meeting	2/14/2005	February 14, 2005 - Committee recommended continued monitoring and future review for the risk of cholelithiasis;
Xenical (orlistat)⁵¹	*9/12/2003	Meeting	4/11/2007	April 11, 2007 (Follow-up) - Committee recommended return to routine monitoring for AEs in all populations.
Glucovance (glyburide/metformin)⁵²	*10/8/2003	Meeting	2/14/2005	February 14, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Arava (leflunomide)⁵³	*11/10/2003	Meeting	6/30/2005	June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Concerta (methylphenidate)⁵⁴	*12/4/2003	Meeting	6/30/2005	June 30, 2005 - Committee was informed of ongoing collaborative study between Duke University, NICHD, and NIH to assess methylphenidate clastogenic potential in children. Committee was updated on efforts to look into psychiatric behavior and cardiovascular for all therapies used for ADHD. The committee agreed to delay making labeling recommendations until the division had completed their examinations of adverse event reports in all stimulant products with respect to psychiatric and cardiovascular risk adverse events. *February 21, 2007* - FDA directs ADHD drug manufacturers to notify patients about cardiovascular adverse events and psychiatric adverse events. See MedGuide and label55 For additional information on ADHD products see Aderall XR March 22, 2006 meeting. June 27, 2008 - revised label
Zemplar (paricalcitol)⁵⁶	*12/8/2003	Meeting	6/30/2005	June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Zomig (zolmitriptan)⁵⁷	*12/18/2003	Meeting	6/30/2005	June 30, 2005 -Committee recommended return to routine monitoring for AEs in all populations.
Ortho-Tri-Cyclen (ethinyl estradiol; norgestimate)⁵⁸	*12/18/2003	Meeting	6/30/2005	June 30, 2005 -Committee recommended return to routine monitoring for AEs in all populations.
Cipro (ciprofloxacin)⁵⁹	*12/18/2003	Meeting	6/30/2005	June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Trusopt (dorzolamide)⁶⁰	*1/5/2004	Meeting	6/30/2005	June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Detrol;Detrol LA (tolterodine)⁶¹	*1/5/2004	Meeting	6/30/2005	June 30, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Agrylin (anagrelide)⁶²	*5/24/2004	Meeting	11/18/2005	November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Paraplatin (carboplatin)⁶³	*4/30/2004	Meeting	11/18/2005	November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Diflucan (fluconazole)⁶⁴	*1/21/2004	Meeting	11/18/2005	November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Camptosar (irinotecan)⁶⁵	*3/10/2004	Meeting	11/18/2005	November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Tamiflu (oseltamivir phosphate)⁶⁶	*3/22/2004	Meeting	11/18/2005	November 18, 2005 - PAC requested follow-up within 2 years on neuropsychiatric (NP) and behavioral events. Labeling⁶⁷. January 17, 2008 - revised label.
Tamiflu (oseltamivir phosphate)⁶⁶	*3/22/2004	Meeting	11/16/2006	November 16, 2006 (Follow-up) - the Committee concurred with previous PAC request for an extensive analysis including (1) a report by the sponsor on NP events; (2) requested FDA invite Japanese experts to report on their experience and ask for Japanese data on the extent of prophylactic use and AEs in said population;
Tamiflu (oseltamivir phosphate)⁶⁶	*3/22/2004	Meeting	11/28/2007	November 28, 2007 (Follow-up) - Committee recommended FDA continue to monitor AEs for Tamiflu on a monthly basis and recommended labeling changes to include: a description of NP symptoms which may occur due to the influenza illness, irrespective of drug therapy; to convey uncertainty in causality of the NP symptoms; to note abrupt appearance of symptoms; and to indicate that "injurious behavior" included fatal outcomes. Similar labeling changes were recommended for the other antiviral influenza medications.
Vioxx (rofecoxib)⁶⁸	*2/18/2004	Meeting	11/18/2005	November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Ferrlecit (sodium ferric gluconate complex in sucrose injection)⁶⁹	*3/24/2004	Meeting	11/18/2005	November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Imitrex (sumatriptan)⁷⁰	2/18/2004	Meeting	11/18/2005	November 18, 2005 - Committee recommended return to routine monitoring for AEs in all populations.
Avapro (irbesartan)⁷¹	*9/16/2004	Meeting	3/22/2006	March 22, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Clolar (clofarabine)⁷²	*3/30/2004	Meeting	3/22/2006	March 22, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Adderall XR (dextroamphetamine saccharate, amphetamine aspirate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)⁷³	*10/28/2004	Meeting	3/22/2006	March 22, 2006 - It was noted that ADHD medications have been shown to be effective in children properly diagnosed with ADHD. The Commitee addressed the adverse events individually: Psychosis/Mania (including hallucinations) -- Labeling for psychosis was warranted and could be further clarified; Stated that it was important to enhance the current warnings in the label regarding psychosis, mania and hallucinations; Aggression -- Parents need to contact physician if new (treatment emergent) aggression occurs or if symptoms of aggression worsen during therapy; Cardiovascular -- Did not request box warning. Committee did request strong warnings recommended MedGuide or information sheet for patients with underlying structural cardiovascular defects or cardiomyopathies; *February 21, 2007* - FDA directs ADHD drug manufacturers to notify patients about cardiovascular adverse events and psychiatric adverse events. See MedGuide and label⁷⁴. May 22, 2007 - revised label
Meridia (sibutramine hydrochloride monohydrate)⁷⁵	*10/6/2004	Meeting	3/22/2006	March 22, 2006 - Committee recommended continued monitoring and requested an update on sibutramine adverse events after completion of the Subutramine Cardiovascular Outcomes (SCOUT) Study.
Rapamune (sirolimus)⁷⁶	*11/17/2004	Meeting	11/16/2006	November 16, 2006 - Committee requested to be informed (email was adequate) about the outcome of discussions with the Sponsor about potential labeling changes concerning pericarditis. October 17, 2007 - adverse reactions section of label modified to include information on pericardial effusion see label⁷⁷
Zofran (ondansetron)⁷⁸	*12/1/2004	Meeting	11/16/2006	November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Avandia (rosiglitazone)⁷⁹	*12/9/2004	Meeting	11/16/2006	November 16, 2006 - Committee recommended that a statement regarding lack of efficacy should also be placed in the pediatric patient information part of the label. The committee noted the current statement is not helpful.
Gemzar (gemcitabine)⁸⁰	*1/27/2005	Meeting	11/16/2006	November 16, 2006 Committee recommended return to routine monitoring for AEs in all population- s.
Invanz (ertapenem)⁸¹	*2/11/2005	Meeting	11/16/2006	November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Zyvox (linezolid)⁸²	*2/11/2005	Meeting	11/16/2006	November 16, 2006 - pending completion of the ongoing review of cardiac events for all age populations by the Office of Surveillance and Epidemiology, the committee requested a report.
Zyvox (linezolid)⁸²	*2/11/2005	Meeting	11/18/2008	November 18, 2008 (Follow-up) - Committee accepted the follow-up report that revealed no new safety signals, but requested to see the completed QT report.
Trileptal (oxcabazepine)⁸³	*3/2/2005	Meeting	11/16/2006	November 16, 2006 The Committee made no recommendation at this time contingent on hearing the division's independent analysis of the suicidality events; in particular they would like a subpopulation analysis focusing on pediatrics (over 2,000 patients) to be provided whenever the division has completed their review.
Trileptal (oxcabazepine)⁸³	*3/2/2005	Meeting	3/25/2008	March 25, 2008 (Follow-up) - Preliminary review of pediatric subpopulation. Further evaluation of entire of adult and pediatric populations pending.
Mobic (meloxicam)⁸⁴	*4/15/2005	Meeting	11/16/2006	November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Novolog (insulin aspart recombinant)⁸⁵	*5/24/2005	Meeting	11/16/2006	November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Amaryl (glimepiride)⁸⁶	*6/9/2005	Meeting	11/16/2006	November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Norvir (ritonavir)⁸⁷	*6/14/2005	Meeting	11/16/2006	November 16, 2006 - Committee recommended return to routine monitoring for AEs in all populations.
Lescol (fluvastatin)⁸⁸	*12/15/2005	Meeting	4/11/2007	April 11, 2007 - Committee recommended routine monitoring for AEs in all populations.
Sandostatin (octreotide)⁸⁹	*1/12/2006	Meeting	4/11/2007	April 11, 2007 - Committee did not believe a causal link was established for necrotizing enterocolitis (NEC) or hypoxia. Because of the increased use of this product in a population at risk for NEC and hypoxia, most members recommended that information on these AEs in this high risk population be placed in the label. Recommended 1 year update focused on observed post marketing adverse events of NEC and hypoxia. Committee members inquired about the need for additional studies, including registries and/or availability of well-controlled trials. January 25, 2010 - revised label.
Sandostatin (octreotide)⁸⁹	*1/12/2006	Meeting	11/18/2008	November 18, 2008 (Follow-up)- Committee agreed with FDA recommendation to harmonize the LAR and Injection Solution versions of the label. Committee recommended that FDA include in the label information about serious pediatric AEs and acknowledge no causal association has been established. Committee recommended that FDA work with NIH regarding a systematic review of actual use and AEs from off-label use. Committee recommended that FDA continue its standard, ongoing safety monitoring.
Serevent (salmeterol)⁹⁰	*3/9/2006	Meeting	11/28/2007	November 28, 2007 - Committee recommended more extensive discussion of benefit/risk of salmeterol with pediatric use and requested a report back to the Committee after additional review of existing data. They recommended labeling changes to include: specifically identifying risks of deaths and increased hospitalizations as potential pediatric adverse risks; updated “Pediatric Use” section with additional safety information; and to provide some quantification of risks. The committee also recommended reorganization of the MedGuide to more prominently display the safety information and straightforwardly present that salmeterol should not be used as monotherapy. Labeling should also reflect the lack of certainty that corticosteroids mitigate serious adverse events. December 10-11, 2008 - A joint meeting of FDA’s Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and Pediatric Advisory Committee met to discuss the risks/benefits of LABA medications after FDA further analysis and recommended removal of asthma indication⁹¹.
Provigil (modafinil)⁹²	*3/21/2006	Meeting	11/28/2007	November 28, 2007 - Committee recommended that the label include the ADHD pediatric clinical trial data and that it include stronger language that it is not approved for any pediatric indication because of safety issues. This information is also to be placed in the PPI part of the label. October 21, 2010 - Label change
Emtriva (emtricitabine)⁹³	*5/24/2006	Meeting	11/28/2007	November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.
Gleevec (imatinib mesylate)⁹⁴	*6/9/2006	Meeting	11/28/2007	November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.
Azopt (Brinzolamide)⁹⁵	*6/28/2006	Meeting	11/28/2007	November 28, 2007 - Committee recommended return to routine monitoring for AEs in all populations.
Betaxon (levobetaxolol)⁹⁶	*6/28/2006	Meeting	11/28/2007	November 28, 2007 - No recommendations. This drug is not marketed.
Toprol XL (metoprolol)⁹⁷	*7/27/2006	Meeting	3/25/2008	March 25, 2008- Committee recommended return to routine monitoring for AEs in all populations.
Celebrex (celecoxib)⁹⁸	*8/23/2006	Meeting	3/25/2008	March 25, 2008 - Committee agreed with the FDA recommendation to have a follow up once data from the postmarketing safety studies have been analyzed.
Colazal (balsalazide)⁹⁹	*8/23/2006	Meeting	3/25/2008	March 25, 2008 - Committee agreed to be updated by email once the labeling change currently being reviewed by the FDA to add postmarking AEs seen in other 5-ASA products in the pediatric population was approved. Committee requested additional information before making a recommendation on monitoring for AEs.
Suprane (desflurane)¹⁰⁰	*9/13/2006	Meeting	3/25/2008	March 25, 2008 - Committee agreed with the FDA proposal to add the adverse event “cardiac arrest” to the labeling. Some members of the committee recommended further restricting the use of this product in pediatrics in the labeling. Others deferred until additional information from pediatric anesthesiologists is provided. Committee recommended continued pediatric focused monitoring. April 14, 2009 - revised label. September 2013, Revised Label
Suprane (desflurane)¹⁰⁰	*9/13/2006	Meeting	6/21/2010	June 21, 2010 (Follow-up) - Committee discussed the importance of enhanced anesthesiology education and training when using this product; the safety issue with using this product in non-intubated patients; and the most common respiratory side effects as laryngospasm, cough, and increased secretions. Committee asked for more prominent labeling for pediatric use to address the need for enhanced warnings for pediatric patients. Committee agreed that the present label does not adequately represent the risks and benefits of this product for its intended use. Committee recommends strengthening the labeling and the use of maintenance in non-intubated pediatric patients be contraindicated.
Eloxatin (oxaliplatin)¹⁰²	*9/27/2006	Meeting	3/25/2008	March 25, 2008 - Committee recommended return to routine monitoring for AEs in all populations.
Coreg (carvedilol)¹⁰³	*11/8/2006	Meeting	3/25/2008	March 25, 2008 - Committee agreed with the FDA recommendation that the labeling be revised to include information on hypoglycemia similar to the text in the propranolol labeling. The Advisory Committee recommended FDA consider adding additional information in labeling regarding PK and the dose which resulted in the inadequate exposure during the trial. Committee recommended return to routine monitoring for AEs in all populations.
Ambien (zolpidem)¹⁰⁴	*11/20/2006	Meeting	11/18/2008	November 18, 2008 - Committee recommended that FDA continue its standard, ongoing safety monitoring.
Lamisil (terbinafine)¹⁰⁵	*12/4/2006	Meeting	11/18/2008	November 18, 2008 - Committee recommended that FDA continue its standard, ongoing safety monitoring.
Aldara (imiquimod)¹⁰⁶	*12/13/2006	Meeting	11/18/2008	November 18, 2008 - Committee requested that text about the negative studies in children as well as local skin reactions in the genital area leading to “inability to urinate” be added to the label. Committee requested that FDA consider including a statement in the Patient Information section that imiquimod was not shown to be effective in children less than 12 years. Committee recommended that FDA continue its standard, ongoing safety monitoring. Oct. 13, 2010 - Labeling change.
Zyprexa (olanzapine)¹⁰⁷	*1/10/2007	Meeting	11/18/2008	November 18, 2008 - Committee requested: (1) additional information regarding pediatric use in this class of products, (2) studies of long-term adverse effects in pediatrics (e.g., metabolic AEs) (3) additional information on movement AEs, and (4) other requests108. The committee agreed with the labeling change proposed by the Division. The labeling was changed January 27, 2010. June 21, 2011 - revised label109
Lamictal (lamotrigine)¹¹⁰	*2/14/2007	Meeting	11/18/2008	November 18, 2008 - Committee supported recommendation made at the July, 2008 AC regarding labeling about suicidality. Committee recommended that FDA continue its standard, ongoing safety monitoring. May 5, 2009 - revised label111.
Risperdal (risperidone)¹¹²	*2/28/2007	Meeting	11/18/2008	November 18, 2008 - Committee requested: (1) additional information regarding pediatric use in this class of products, (2) studies of long-term adverse effects in pediatrics (e.g., metabolic AEs) (3) additional information on movement AEs, and (4) other requests113101. The committee agreed with the labeling change proposed by the Division. The labeling was changed August 30, 2010. March 12, 2012 - Revised Label
Betoptic S (betaxolol)¹¹⁴	*2/28/2007	Meeting	11/18/2008	November 18, 2008 - Committee recommended that FDA return to routine monitoring for AEs
Timolol GFS (timolol)¹¹⁵	*2/28/2007	Meeting	11/18/2008	November 18, 2008 - Committee recommended that FDA return to routine monitoring for AEs
Levaquin (levofloxacin)¹¹⁶	*3/14/2007	Meeting	11/18/2008	November 18, 2008 - Committee recommended that FDA revise the label to include text about other drug products known to cause prolonged QT interval. FDA to continue its standard, ongoing safety monitoring.
Combigan (brimonidine/timolol)¹¹⁷	10/30/2007	Meeting	6/23/2009	June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Derma-Smoothe/FS (fluocinolone acetonide)¹¹⁸	12/12/2007	Meeting	6/23/2009	June 23, 2009 Recommended that the FDA consider modifying label to reflect there had been actual cases of peanut allergic reactions and that it was not just a hypothetical concern.
Hepsera (adefovir dipivoxil)¹¹⁹	12/19/2007	Meeting	6/23/2009	June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Inspra (eplerenone)¹²⁰	1/31/2008	Meeting	6/23/2009	June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Moxatag (amoxicillin)¹²¹	1/23/2008	Meeting	6/23/2009	June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Alvesco (ciclesonide)¹²²	1/10/2008	Meeting	6/23/2009	June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Omnaris (ciclesonide)¹²³	11/21/2007	Meeting	6/23/2009	June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs
Zometa (zoledronic acid)¹²⁴	3/20/2008	Meeting	6/23/2009	June 23, 2009 Committee recommended that FDA return to routine monitoring for AEs.
Diovan (valsartan)¹²⁵	11/29/2007	Meeting	6/23/2009	June 23, 2009 Committee recommended FDA revise labeling to put additional emphasis on the potential for development of pulmonary hypoplasia. Committee recommended that FDA return to routine monitoring for AEs.
Asmanex (mometasone furoate)¹²⁶	2/1/2008	Meeting	6/23/2009	June 23, 2009 Committee recommended labeling be revised to clearly state that lactose is an ingredient in the excipient powder and recommended to harmonize the labeling for all dry product inhalers. Committee recommended that FDA return to routine monitoring for AEs. Sept. 17, 2010 - Labeling changed.
AndroGel (testosterone)¹²⁷	12/27/2007	Meeting	6/23/2009	June 23, 2009 Committee recommended FDA examine the effects of low level secondary exposure and encourage studies of the transfer of drug product from inanimate objects to people. The Committee also provided specific labeling recommendations including (1) revising text using descriptive, easy to understand language, (2) defining the term “virilization” for the consumer, (3) adding information on the pediatric studies performed and the risks, other than just bone effects, of secondary exposure to Section 8.4 Pediatric Use, and (4) revising the illustration in Section 17.3 FDA-Approved patient Labeling to be consistent with application instructions. The Committee recommended measures be taken immediately to reduce risk of exposure, including changing skin application sites and limiting use in families with children. September 18, 2009, revised label¹²⁸
Depakote (divalproex sodium)¹²⁹	3/24/2008	Meeting	6/23/2009	June 23, 2009 Committee agreed to FDA continuing its review and analysis of neurodevelopmental delay associated with fetal exposure to Depakote (divalproex sodium). If any additional safety signal emerges or a pediatric labeling change is made, a report to the Committee will be provided. December 7, 2010 - Committee updated with the analysis on the neurodevelopment delay information.
Zetia/Vytorin (ezetimibe/simvastatin)¹³⁰	6/5/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Aptivus (tipranavir)¹³¹	6/23/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Reyataz (atazanavir Sulfate)¹³²	3/25/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended that FDA encourage the sponsor to increase its effort to submit more data in order to obtain dosing information for the age group 3 months to 6 years. Committee recommended return to standard, ongoing, monitoring for adverse events.
Kaletra (topinavir/ritonavir)¹³³	11/9/2007 & 6/20/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events. September 22, 2011 - Committee was given an informational update. December 2011,revised label134
Argatroban (argatroban)¹³⁵	5/5/2008	Meeting	12/8/2009	December 8, 2009 Committee requested that FDA encourage sponsor to study and report more information on dosing this product for pediatric patients with HIT. Committee recommended return to standard, ongoing monitoring for adverse events.
Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection)¹³⁶	12/27/2007	Meeting	12/8/2009	December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Evicel [fibrin sealant (human)]¹³⁷	1/2/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Artiss [fibrin sealant (human)]¹³⁸	3/19/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended that FDA consider revising the label to include information on specific ages of those studied in the pre-market clinical trials. Committee discussed the use of this product in very young children with burns. And recommended that its use be studied in children less than 1 year. Committee recommended return to standard, ongoing monitoring for adverse events.
Cancidas (caspofungin)¹³⁹	7/29/2008	Meeting	12/8/2009	December 8, 2009 Committee agreed that FDA: 1) update the labeling to clarify the hepatobiliary events that have been reported in pediatric and adult patients; 2) conduct a study in infants who were less than 3 months of age who had fungal infections and needed this therapy; 3) return to standard, ongoing monitoring for adverse events. January 28, 2010, revised label¹⁴⁰.
Ventolin HFA (albuterol)¹⁴¹	3/26/2008	Meeting	12/8/2009	December 8, 2009 Committee discussed route of drug administration (HFA and nebulizer) for children 0-4 years of age and discussed the safety risk from lack of efficacy for this product for children less than 4. Committee recommended that FDA return to ongoing safety monitoring, and recommended that the label be amended to include additional information including warnings for children 0-4 years of age.
Orencia (abatacept)¹⁴²	4/7/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Humira (adalimumab)¹⁴³	2/21/2008	Meeting	12/8/2009	December 8, 2009 Committee recommended return to standard, ongoing monitoring for adverse events.
Abilify (aripiprazole)¹⁴⁴	10/29/2007 & 2/27/2008	Meeting	12/8/2009	December 8, 2009 Committee did not support that the labeling adequately reflects the possible risk of pediatric weight gain and recommends additional information on weight gain be added. The Committee requested that FDA review the use data on atypical antipsychotics for children with a diagnosis of ADHD. Committee recommended return to standard, ongoing monitoring for adverse events.
Lancome UV Expert; 40 La Roche-Posay; Anthelios 40 Vichy; Capital Soleil 40¹⁴⁵	3/31/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Cardiolite (technetium Tc99m)¹⁴⁶	4/30/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Nasacort AQ (triamcinolone)¹⁴⁷	9/19/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Viramune (nevirapine)¹⁴⁸	6/24/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)¹⁴⁹	3/12/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)¹⁵⁰	6/24/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)¹⁵¹	6/20/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Rotarix (Rotavirus Vaccine, Live, Oral)¹⁵²	4/3/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Valtrex (valacyclovir)¹⁵³	9/3/2008	Meeting	3/22/2010	March 22, 2010 Committee agreed with FDA plan to update the labeling to clarify that central nervous system adverse reactions have been reported in pediatric and adult patients. Committee recommended return to standard, ongoing monitoring for adverse events.
Zmax (arithromycin)¹⁵⁴	10/8/2008	Meeting	3/22/2010	March 22, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Casodex (bicalutamide)¹⁵⁵	12/19/2008	Meeting	3/22/2010	June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Apidra (insulin glulisine recombinant)¹⁵⁶	10/24/2008	Meeting	6/21/2010	June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events and medication errors, including device failures associated with insulin delivery systems.
NovoLog (insulin aspart (rDNA))¹⁵⁷	3/14/2008	Meeting	6/21/2010	June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events and medication errors, including device failures associated with insulin delivery systems.
Arimidex (anastrozole)¹⁵⁸	12/5/2008	Meeting	6/21/2010	June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Desmopressin Acetate¹⁵⁹	5/8/2008	Meeting	6/21/2010	June 21, 2010 Committee discussed the increased tablet use in conjunction with the removal of the nasal formulation. Committee recommended return to standard, ongoing monitoring for adverse events.
Prevacid (lansoprazole)¹⁶⁰	10/28/2008	Meeting	6/21/2010	June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
Nexium (esomeprazole magnesium)¹⁶¹	2/27/2008 & 6/18/2009	Meeting	6/21/2010	June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
Aciphex (rabeprazole)¹⁶²	6/30/2008	Meeting	6/21/2010	June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
Prilosec (omeprazole)¹⁶³	3/20/2008	Meeting	6/21/2010	June 21, 2010 Committee discussed the need for additional data to evaluate treated symptoms, dosing schemes, and bone fractures issues related to Proton Pump Inhibitor (PPI) use. Committee requested updates after the upcoming Advisory Committee Meeting on PPIs and neonatal study endpoints. Based on the above they recommended return to standard, ongoing monitoring for adverse events.
OraVerse Injection (phentolamine mesylate)¹⁶⁴	5/9/2008	Meeting	6/21/2010	June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Zemuron (rocuronium)¹⁶⁵	8/28/2008	Meeting	6/21/2010	June 21, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Kogenate FS (antihemophilic factor (recombinant))¹⁶⁶	10/10/2008	Meeting	6/21/2010	June 21, 2010 Committee discussed the importance of developing databases to identify pediatric usage for products intended to treat rare diseases such as Kogenate FS. Committee recommended return to standard, ongoing monitoring for adverse events.
Acanya Gel (clindamycin/benzoyl peroxide combo)¹⁶⁷	10/21/2008	Meeting	12/7/2010	December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Ulesfia Lotion 5% (benzl alcohol)¹⁶⁸	4/9/2009	Meeting	12/7/2010	December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Epiduo Gel (adapalene & benzoyl peroxide)¹⁶⁹	12/17/2008	Meeting	12/7/2010	December 7, 2010 Committee recommended to revise the label to include potential for patient hypersensitivity to the product and a follow-up after label revision. Feburary 18, 2011 - Revised Label
Gardasil [Human Papillomavirus Quadrivalent (types 6, 11, 16, 18) vaccine recombinant]¹⁷⁰	9/12/2008	Meeting	12/7/2010	December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events. The committee also expressed the need for improved communication between physicians and their patients regarding the potential for syncope associated with the injection of the vaccine.
Xyzal (levocetirizine dihydrochloride)¹⁷¹	8/21/2009	Meeting	12/7/2010	December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events. The committee suggested that FDA should monitor and compare adverse events between Xyzal and Zyrtec, and other anti-histamines, to identify whether there are trends of neuropsychiatric adverse events.
Flovent HFA (fluticasone propionate)¹⁷²	7/1/2008	Meeting	12/7/2010	December 7, 2010 Committee recommends adding dental caries and tooth discoloration to the post-marketing section of the label; advocate growth studies in children 0 to 4 years of age and revise the label to explain that the efficacy of the drug has not been established in patients <4 years="" of="">
Neulasta (pegfilgrastim)¹⁷³	11/14/2008	Meeting	12/7/2010	December 7, 2010 Committee agreed to no labeling change; retain the pediatric PK information in the labeling; and to wait until FDA has completed its pediatric medication error review before adding information to the labeling.
Prezista (darunavir ethanolate)¹⁷⁴	12/18/2008	Meeting	12/7/2010	December 7, 2010 Committee agreed to a follow-up after the following has taken place: review of AEs across the class of drugs; review autoimmune response in all HIV anti-viral products; review of immune reconstitution syndrome (IRS) literature of all populations with all autoimmune AEs.
PegIntron (peginterferon alfa-2b)¹⁷⁵	12/11/2008	Meeting	12/7/2010	December 7, 2010 Committee agreed to a follow-up after the FDA considers the effect associated with use of product and liver transplant; complete class review; and labeling has been revised.
Axert (almotriptan)166¹⁷⁶	4/30/2009	Meeting	12/7/2010	December 7, 2010 Committee recommended return to standard, ongoing monitoring for adverse events.
Lamictal XR (lamotrigine)¹⁷⁷	5/29/2009 & 1/29/2010	Meeting	12/7/2010	December 7, 2010 Committee agreed to a follow-up after a labeling revision which includes lactation data from the literature and ongoing studies is completed.
Lamictal (lamotrigine)	5/8/2009	Meeting	12/7/2010	December 7, 2010 Committee agreed to a follow-up after a labeling revision which includes lactation data from the literature and ongoing studies is completed.
HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)¹⁷⁸	8/19/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Bepreve (bepotastine besilate)¹⁷⁹	9/8/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Besivance (besifloxacin)¹⁸⁰	5/28/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Cetraxal (ciprofloxacin otic)¹⁸¹	5/1/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Patanase Spray (olopatadine hydrochloride)¹⁸²	4/15/2008 & 12/1/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Astepro spray(azelastine hydrocholoride)¹⁸³	8/31/2009	Meeting	5/16/2011	May 16, 2011 - Committee requested a focused use review on all pediatric adverse events since marketing (2009). Committee recommended return to standard, ongoing monitoring for adverse events.
Crestor (rosuvastatin)¹⁸⁴	10/15/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Welchol (colesevelam)¹⁸⁵	10/2/2009	Meeting	5/16/2011	May 16, 2011 - Committee discussed the new granular formulation and its impact on the 2 to 10 year old population. Requested a focused use review. Committee recommended return to standard, ongoing monitoring for adverse events.
Intuniv (guanfacine)¹⁸⁶	9/2/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Lexapro (escitalopram oxalate)¹⁸⁷	3/19/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Actonel (risedronate)¹⁸⁸	7/23/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Valcyte (valganciclovir)¹⁸⁹	8/28/2009	Meeting	5/16/2011	May 16, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Retrovir (zidovudine)¹⁹⁰	9/19/2008 & 11/6/2009	Meeting	9/22/2011	September 22, 2011 - Committee agreed with the FDA recommendation for dosing changes to reduce medication errors and recommended a follow-up after changes have been implemented. Revised labeling, 5/2012 191
Ziagen (abacavir)¹⁹²	12/19/2008	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Topamax (topiramate)¹⁹³	12/22/2009	Meeting	9/22/2011	September 22, 2011 - Committee recommended labeling change to better define pediatric experience with adverse events of weight loss, bone mineralization, and particularly the life threatening nature of some episodes of epistaxis. They also strongly recommend that information from the adolescent migraine study be added to the label. Revised Label194, 3/2014
Navstel Intraocular Irrigating Solution Sterile (balanced salt ophthalmic solution with hypromellose, dextrose & glutathione)¹⁹⁵	7/24/2008	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Akten Ophthalmic (lidocaine hydrochloride ophthalmic gel 3.5%)¹⁹⁶	10/7/2008	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Triesence (trimcinolone acetonide injectable suspension)¹⁹⁷	11/29/2007	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Melody Transcatheter Pulmonary Valve and Ensemble Delivery System¹⁹⁸, initial review	1/25/2010	Meeting	9/22/2011	September 22, 2011 - Committee agreed that the HDE device is appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
FLUARIX Influenza virus vaccine¹⁹⁹	10/19/2009	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
AFLURIA Infuenza virus vaccine²⁰⁰	11/10/2009	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Famvir (famciclovir)²⁰¹	12/24/2009	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Videx EC (didanosine)²⁰²	9/29/2008	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Abilify (aripiprazole)²⁰³	11/19/2009	Meeting	9/22/2011	September 22, 2011 - Committee recommended language to clarify the potential for metabolic and weight effects in the pediatric population and a follow-up 12-18 months after labeling change. February 22, 2012, revised label²⁰⁴
Zomig Nasal Spray(zolmitriptan)²⁰⁵	10/14/2008	Meeting	9/22/2011	September 22, 2011 - Committee recommended return to standard, ongoing monitoring for adverse events.
Levaquin (levofloxacin)²⁰⁶	5/5/2008	Meeting	9/22/2011	September 22, 2011 - Committee recommended that information on anthrax emergency response be added to the indication and usage sections in the label. Committee recommended return to standard, ongoing monitoring for adverse events.
Focalin XR (dexmethylphenidate hydrochloride)²⁰⁷	12/23/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. They also recommended revisions to the label to include; strengthening text regarding hallucinations, suicidality, and extrapyramidal symptoms. Committee agreed with FDA’s plan to add angioedema and anaphylaxis to the label. Committee requested a follow up presentation after a labeling revision and harmonizing the labels for all methylphenidate products are completed.
Daytrana (methylphenidate)²⁰⁸	12/14/2009 & 6/29/2010	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Seroquel (quetiapine fumarate)²⁰⁹	12/2/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Xolair (omalizumab)²¹⁰	1/4/2010	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. PAC discussed adding an informational website link to the package insert.
Plan B One-Step (levonorgestrel)²¹¹	7/10/2009	Meeting	1/30/2012	January 30, 2012 Committee recommended return to standard, ongoing monitoring for adverse events.
Flomax (tamsulosin hydrochloride)²¹²	12/22/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Atacand (candesartan cilexetil)²¹³	10/22/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee wanted a follow up when all the ACE inhibitor products were harmonized with regards to the pregnancy labeling.
Benicar (olmesartan medoxomil)²¹⁴	2/4/2010	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee wanted a follow up when all the ACE inhibitor products were harmonized with regards to the pregnancy labeling. February 15, 2012, label revised²¹⁵.
Pancreaze (pancrelipase)²¹⁶	4/12/2010	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. It was suggested to FDA that more information be added to the label dosing instructions regarding the volume amount to be used with the product.
Zenpep (pancrelipase)²¹⁷	8/27/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. It was suggested to FDA that more information be added to the label dosing instructions regarding the volume amount to be used with the product.
Creon (pancrelipase)²¹⁸	4/30/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. It was suggested to FDA that more information be added to the label dosing instructions regarding the volume amount to be used with the product.
Xerese (acyclovir/hydrocortisone)²¹⁹	7/31/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Mirena (levonorgestrel releasing intrauterine system)²²⁰	10/1/2009	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Prevnar 13 [pneumococcal 13-valent conjugate vaccine (diptheria CRM197 protein)]²²¹	2/24/2010	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee raised questions about a possible safety signal related to the SIDS cases.
Cervarix (human papilloma virus bivalent (types 16 & 18) vaccine recombinant)²²²	10/16/2009 & 7/19/2011	Meeting	1/30/2012	January 30, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Tamiflu (oseltamivir phosphate)²²³	2/22/2010	Meeting	5/7/2012	May 7, 2012- Committee commended FDA on its extensive safety review of this product over the last decade and recommended return to standard, ongoing monitoring for adverse events.
Viread (tenofovir disoproxil fumate)²²⁴	3/24/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Differin (adapalene)²²⁵	3/17/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee requested an update after the review is completed.
MultiHance (gadobenate dimeglumine)²²⁶	3/17/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Dulera (formoterol fumarate; mometasone furoate)²²⁷	6/22/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events in the 5 - 11 year olds. Committee discussed safety issues in the < 5="" year="" old="" age="" group="" and="" need="" for="" additional="" clarity="" in="" labeling="" concerning="" not="" using="" this="" product="" in="" under="" 5="" year="" olds.="" committee="" recommended="" more="" information="" be="" added="" to="" the="" label="" regarding="" aggressive="" behavior="" and="" neuropsychiatric="" events="" in="" the="">< 5="" year="" olds.="" the="" committee="" discussed="" additional="" ways="" to="" inform="" providers/caretakers="" concerning="" this="" issue.="" the="" committee="" requested="" follow-up="" on="" labeling="" changes,="" adverse="" events="" and="" an="" update="" after="" trials="" for="" the="" 5/2011="" year="" olds="" are="">
Nasonex (mometasone furoate monohydrate)²²⁸	5/26/2010 & 1/19/2011	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Taxotere (docetaxel)²²⁹	5/13/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Omnaris (ciclesonide)²³⁰	5/7/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Natazia (dienogest; estradiol valerate)²³¹	5/6/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Protonix (pantoprazole sodium)²³²	11/12/2009	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
MENVEO Meningococcal (Groups A,C,Y and W/20135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine²³³	2/19/2010 & 1/28/2011	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine Recombinant²³⁴	10/16/2009 & 12/22/2010	Meeting	5/7/2012	May 7, 2010 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee also expressed the need for improved communication between physicians and their patients regarding the potential for syncope associated with the injection of the vaccine.
Zymaxid (gatifloxacin)²³⁵	5/18/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Zylet (loteprednol etabonate and tibramycin)²³⁶	6/3/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Isopto Carpine (pilocarpine hydrochloride²³⁷	6/22/2010	Meeting	5/7/2012	May 7, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Kapvay (clonidine hydrochloride)²³⁸	9/28/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended harmonizing labeling with the clonidine IR label for AV block and hallucinations, and return to standard, ongoing monitoring for adverse events. February, 2013 - Revised Label²³⁹
Vyvanse (lisdexamfetamine dimesylate)²⁴⁰	11/10/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events and to be notified after class labeling for ADHD medications is completed.
Beyaz (drospirenone/ethinyl estradiol/ levomefolate calcium tablets and levomefolate calcium tablets)²⁴¹	9/24/2010	Meeting	9/11/2012	September 11, 2012 - The Committee raised concerns about the risk of venous thromboembolism with drospirenone products, and asked that FDA consider strengthening the label. They expressed the need for studies/assessments in the younger adolescent population. Though the majority voted for a return to routine monitoring there were many “conditions” applied please see Minutes of the Meeting.²⁴²
ella (ulipristal acetate)²⁴³	8/13/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate)²⁴⁴	10/21/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Afinitor (everolimus)²⁴⁵	10/29/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Ofirmev (acetaminophen)²⁴⁶	11/2/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events, and recommended labeling for every 4 hours versus every 6 hours, and discussed having only mg dosing in the label.
Lastacaft (alcaftadine)²⁴⁷	7/28/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Aridol (mannitol inhalation powder) Bronchial Challenge Test Kit²⁴⁸	10/5/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Augmentin XR (amoxicillin/clavulanate potassium)²⁴⁹	8/27/2010	Meeting	9/11/2012	September 11, 2012 - Committee recommended return to standard, ongoing monitoring for adverse events.
Melody Transcatheter Pulmonary Valve and Ensemble Delivery System²⁵⁰ mandated annual review	1/25/2010	Meeting	9/11/2012	September 11, 2012 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
Elana Surgical Kit (HUD)²⁵¹, initial review	3/10/2011	Meeting	9/11/2012	September 11, 2012 - Committee agreed that the HDE device remains appropriately approved and labeled for pediatric use and recommended return to standard, ongoing monitoring for adverse events.
MENACTRA Meningococcal Polysaccharide (Serogroup A, C, Y and W/20135) Diphtheria Toxoid Conjugate Vaccine²⁵²	4/22/2011	Meeting	3/14/2013	March 14, 2013 - Committee recommended return to routine monitoring for adverse events and follow-up information on the Post-market Commitment Stage 1 study in 9-23 month olds after the data is reviewed.
HIZENTRA Immune Globulin Subcutaneous (Human) 20% Liquid²⁵³	2/17/2011	Meeting	3/14/2013	March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events. More utilization information is needed for the CBER products.
ALIMTA (pemetrexed disodium)²⁵⁴	3/17/2011	Meeting	3/14/2013	March 14, 2013 - Committee recommended return to ongoing monitoring for adverse events.
GADAVIST (gadobutrol)²⁵⁵	3/14/2011	Meeting	3/14/2013	March 14, 2013 - Committee recommended return to ongoing monitoring for adverse events. Committee discussed the issues of the cases being confounded and hypersensitivity reactions may be related to latex or other drugs.
KEDBUMIN Albumin (Human)²⁵⁶	6/1/2011	Meeting	3/14/2013	March 14, 2013 - Committee recommended return to standard, ongoing monitoring for adverse events. Committee recommended that more utilization data be available for review of the CBER products.
NATROBA (spinosad)²⁵⁷	1/18/2011	Meeting	3/14/2013	March 14, 2013 - Committee recommended return to ongoing safety monitoring for adverse events.
UROXATRAL (alfuzosin hydrochloride)²⁵⁸	12/15/2010	Meeting	3/14/2013	March 14, 2013 - Committee recommended return to ongoing safety monitoring for ad