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FDA Pediatric Safety Communications

Date Product(s) Announcement
February 8, 2022 Enteral Feeding Delivery Sets Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets
September 1, 2021 Xeljanz and Xeljanz XR (tofacitinib) FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
July 15, 2021 NuVasive MAGEC System Implants FDA reports potential concerns with NuVasive MAGEC System Implants
July 14, 2021 Specific NEUTROGENA® and AVEENO® aerosol sunscreen products FDA reports that Johnson & Johnson Consumer Inc. issued a voluntary recall of specific NEUTROGENA® and AVEENO® aerosol sunscreen products due to the presence of benzene
July 7, 2021 Hydroxyethyl starch (HES) products FDA requires labeling changes on mortality, kidney injury, and excess bleeding with hydroxyethyl starch products
June 16, 2021 Alcohol-based hand sanitizers FDA warns that vapors from alcohol-based hand sanitizers can have side effects
June 14, 2021 Designed By Nature goat’s milk, cow’s milk and base milk formulas FDA reports that Designed By Nature voluntarily recalls goat’s milk, cow’s milk and base milk formulas due to possible health risk
March 31, 2021 Lamotrigine (Lamictal) An FDA review of studies shows a potential increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease
March 25, 2021 Propylhexedrine FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm
February 24, 2021 Homemade infant formula FDA advises parents and caregivers to not make or feed homemade infant formula to infants
February 12, 2021 Pulse oximeters FDA informs patients and health care providers about pulse oximeter accuracy and limitations
February 9, 2021 COVID-19 vaccines FDA monitors COVID-19 vaccine safety
January 4, 2021 Curative SARS-Cov-2 test FDA warns of the risk of false results with the Curative SARS-Cov-2 test for COVID-19
October 28, 2020 Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products FDA reports that Sunstar Americas, Inc. is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products due to possible contamination with the bacteria Burkholderia lata
September 24, 2020 Diphenhydramine (Benadryl) FDA warns about serious problems with higher than recommended doses of the allergy medicine diphenhydramine (Benadryl)
September 24, 2020 Dental amalgam FDA provides recommendations about the use of dental amalgam in certain high-risk populations
September 23, 2020 Metformin hydrochloride (Riomet ER) FDA reports that Sun Pharmaceutical Industries, Inc. is issuing a voluntary nationwide recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) due to N-nitrosodimethylamine content above the acceptable daily intake limit
September 23, 2020 Benzodiazepines FDA requires Boxed Warning updated to improve safe use of benzodiazepine drug class
August 27, 2020 Hand sanitizers FDA updates on hand sanitizers consumers should not use
July 23, 2020 Naloxone FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
July 2, 2020 Hand sanitizers contaminated with methanol FDA warns consumers of risk of methanol contamination in certain hand sanitizers
June 19, 2020 Hand sanitizers contaminated with methanol FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol)
March 10, 2020 HiRes Ultra and Ultra 30 cochlear implant devices FDA reports that Advanced Bionics will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipients
March 4, 2020 Montelukast (Singulair) FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis
February 27, 2020 Ozone and ultraviolet (UV) light products for cleaning continuous positive airway pressure (CPAP) devices and accessories FDA reports potential risks associated with the use of unauthorized ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories (no ozone/UV cleaning products are currently approved)
December 19, 2019 Gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) FDA warns about serious breathing problems for patients with respiratory risk factors taking seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
November 5, 2019 Biotin FDA warns that biotin may interfere with lab tests: update to 2017 Safety Communication
August 30, 2019 E-cigarette products FDA warns of incidents of severe respiratory disease associated with use of an e-cigarette product
August 28, 2019 Mavyret, Zepatier, Vosevi

FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease

June 27, 2019 Certain Medtronic MiniMed™ insulin pumps FDA warns about potential cybersecurity vulnerabilities affecting certain Medtronic MiniMed insulin pumps
June 7, 2019 Flavored e-liquid products FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf
June 7, 2019 Bobbie Baby Inc. infant formula FDA advises consumers to stop using infant formula from Bobbie Baby Inc
May 17, 2019 Continuous glucose monitoring systems (CGMs), insulin pumps, or automated insulin dosing (AID) systems FDA warns people with diabetes and health care providers against the use of devices for diabetes management not authorized for sale in the United States
May 7, 2019 Medtronic pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) FDA alerts providers and patients to check for premature battery depletion in certain Medtronic pacemakers
April 10, 2019 Medical devices for concussion diagnosis, treatment, or management without FDA approval or clearance FDA recommends only using cleared or approved medical devices to help assess or diagnose a head injury, including concussion
April 9, 2019 Opioid pain medicines FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
April 8, 2019 Previously owned test strips FDA warns against use of previously owned test strips or test strips not authorized for sale in the United States
March 21, 2019 Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors FDA warns about cybersecurity vulnerabilities affecting Medtronic implantable cardiac devices, programmers, and home monitors
March 20, 2019 DG™/health NATURALS baby Cough Syrup + Mucus FDA posts Kingston Pharma, LLC recall of " DG™/health NATURALS baby Cough Syrup + Mucus” as a public service because of possible health risk
March 6, 2019 Zoll LifeVest 4000 Wearable Cardioverter Defibrillator FDA updates warning on Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - software update for potential lack of treatment (shock) delivery due to device failure
December 20, 2018 Teething jewelry (includes necklaces, bracelets and other jewelry) FDA warns against use of teething necklaces, bracelets, and other jewelry marketed for relieving teething pain or providing sensory stimulation
December 20, 2018 Fluoroquinolone antibiotics FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients
November 20, 2018 Gilenya (fingolomid) FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
November 16, 2018 Honey pacifiers FDA reports that honey pacifiers are suspected in Texas infant botulism cases
November 15, 2018 Flavored tobacco products, menthol in cigarettes FDA Commissioner Scott Gottlieb, M.D., issues a statement on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
November 1, 2018 Genetic laboratory tests claiming to predict response to specific medications FDA warns against the use of many genetic tests with unapproved claims to predict patient response to specific medications
September 12, 2018 E-cigarettes FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access
August 3, 2018 Zithromax, Zmax (azithromycin) FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant
July 10, 2018 Fluoroquinolone antibiotics FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes
May 23, 2018 Over-the-counter (OTC) oral drug products containing benzocaine FDA warns about oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics because of risk of serious and potentially fatal blood disorder.
May 18, 2018 Products containing dolutegravir (Juluca, Tivicay, Triumeq) FDA evaluates potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
Apr. 25, 2018 Lamictal (lamotrigine) FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal).
February 22, 2018 Biaxin (clarithromycin) FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease.
January 30, 2018 Over-the counter (OTC) anti-diarrhea drug loperamide FDA limits packaging for anti-diarrhea medicine loperamide (Imodium) to encourage safe use.
January 11, 2018 Prescription cough and cold medicines containing codeine or hydrocodone FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
December 20, 2017 Long-acting beta agonists (LABAs) FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)
December 19, 2017 Gadolinium-based contrast agents (GBCAs) FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
May 22, 2017  Gadolinium-based contrast agents (GBCAs) FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue

Please refer to the updated Drug Safety Communication for GBCAs dated December 19, 2017
Apr. 27, 2017 General Anesthetic and Sedation Drugs FDA approves label changes for use of general anesthetic and sedation drugs in young children
Apr. 20, 2017 Codeine and tramadol containing products FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
Jan. 27, 2017 Hyland's belladonna-containing homeopathic teething products FDA confirms elevated levels of belladonna in certain homeopathic teething products.
Dec. 14, 2016 General anesthetics and sedation drugs FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women
Aug. 31, 2016 The combination of opioid pain or cough medicines with benzodiazepines FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
July 26, 2016 Oral and injectable flouroquinolone antibiotics FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
June 7, 2016 Imodium (loperamide) FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse
June 6, 2016 Over-the-counter antacid products containing aspirin (such as Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever) FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
May 12, 2016 Flouroquinolone antibiotics FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
May 10, 2016 Zyprexa, Zyprexa Zydis, Zyprexa Relprevy, Symbyax (olanzapine) FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
May 3, 2016 Abilify, Abilify Maintena, Aristada (aripprazole) FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
April 8, 2016 Metformin FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function
March 22, 2016 Opioid pain medicines FDA warns about several safety issues with opioid pain medicines; requires label changes
Jan. 4, 2016 Noxafil (posaconazole) FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved
Nov. 17, 2015 Iodine-containing Contrast Agents (Cystografin, MD-76R,Cholografin Meglumine,Visipaque, Omnipaque, Isovue,Ultravist, Conray, Optiray,Hexabrix, Oxilan) FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging
Sept. 21, 2015 Ultram, Ultram ER, Conzip, and generics (tramadol) FDA evaluates the risks of using the pain medicine tramadol in children aged 17 and younger
July 16, 2015 Proglycem (diazoxide) FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide)
July 1, 2015 Codeine cough and cold medicines FDA evaluates the potential risks of using codeine cough-and-cold medicines in children
June 26, 2014 Oral viscous lidocaine 2% solution FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning
June 25, 2014 Over- the-counter acne products (such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean&Clear, and as store brands) FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products
Mar. 31, 2014 Revatio (sildenafil) FDA clarifies warning about pediatric use of Revatio (sildenafil) for pulmonary arterial hypertension
Dec. 17, 2013 Concerta (methylphenidate hydrochloride), Daytrana (methylphenidate), Focalin and Focalin XR (dexmethylphenidate hydrochloride), Metadate CD and Metadate ER (methylphenidate hydrochloride), Methylin and Methylin ER (methylphenidate hydrochloride), Quillivant XR (methylphenidate hydrochloride), Ritalin, Ritalin LA, and Ritalin SR (methylphenidate hydrochloride) FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes.
Feb. 26, 2013 Sensipar (cinacalcet hydrochloride) FDA suspends clinical studies of Sensipar (cinacalcet hydrochloride) after report of death
Feb. 20, 2013 Codeine and Codeine-Containing Products FDA updates safety review of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy.
Oct. 25, 2012 Over the-counter tetrahydrozoline, oxymetazoline, or naphazoline containing eye drops and nasal decongestant sprays FDA reports serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays
Aug. 30, 2012 Revatio (silfenadil) FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension
Aug. 15, 2012 Codeine and Codeine-Containing Products FDA warns that codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death
June 29, 2012 Zofran (ondansetron) FDA reports new information regarding QT prolongation with ondansetron (Zofran)
Dec. 22, 2011 Acetaminophen FDA informs the public of another concentration of liquid acetaminophen marketed for infants
Dec. 14, 2011 Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone) FDA reports the potential risk of a rare heart and lung condition in newborn babies associated with the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy
Nov. 3, 2011 Tumor necrosis factor (TNF) blockers [Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab) FDA provides a safety update Tumor Necrosis Factor (TNF) blockers and the risk for pediatric malignancy
Nov. 1, 2011 Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate), Focalin, Focalin XR (dexmethylphenidate), Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostate (dextroamphetamine sulfate), Vyvanse (lisdexamfetamine dimesylate), Adderall, Adderall XR (amphetamine, mixed salts), Desoxyn (methamphetamine), Cylert- no longer marketed (pemoline), Strattera (atomoxetine) FDA provides a safety update of medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults
Sep. 15, 2011 Zofran (ondansetron) FDA reports abnormal heart rhythms may be associated with use of Zofran (ondansetron)
Aug. 4, 2011 Recombinant Human Growth Hormone (somatropin) FDA provides a safety update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
July 11, 2011 Tamiflu (oseltamivir phosphate) for Oral Suspension FDA reports important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension
June 30, 2011 Valproate sodium, valproic acid, divalproex sodium FDA reports that children born to mothers who took Valproate products while pregnant may have impaired cognitive development
May 20, 2011 SimplyThick FDA warns healthcare professionals and the public not to feed SimplyThick to infants born before 37 weeks gestation because of the risk of necrotizing enterocolitis (NEC)
April 15, 2011 Long-acting beta agonists (LABAs): Symbicort (budesonide and formoterol), Advair Diskus (fluticasone and salmeterol), Dulera (mometasone and formoterol), Foradil, Foradil with fluticasone (formoterol) FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)
Mar. 8, 2011 Kaletra (lopinavir/ritonavir) FDA warns of serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution
Feb. 22, 2011 Antipsychotic drugs FDA updates antipsychotic drug labels on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns
Jan. 12, 2011 Lantus (insulin glargine) FDA provides an update to an ongoing safety review of Lantus (insulin glargine) and possible risk of cancer
Dec. 14, 2010 Tessalon (benzonatate) FDA reports a death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age
Sep. 15, 2010 Valcyte (valganciclovir hydrochloride) FDA provides new dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients
Aug. 12, 2010 Lamictal (lamotrigine) FDA reports aseptic meningitis associated with use of Lamictal (lamotrigine)
July 29, 2010 Evamist (estradiol transdermal spray) FDA reports an ongoing safety review of Evamist (estradiol transdermal spray) and unintended Ongoing exposure of children and pets to topical estrogen
June 15, 2010 Vitamin D Supplement Products FDA reports infant overdose risk with liquid Vitamin D
June 2, 2010 Serevent Diskus (Salmeterol); Foradil Aerolizer (Formoterol); Foradil Certihaler* (Formoterol); Advair Diskus (Salmeterol/Fluticasone); Advair HFA (Salmeterol/Fluticasone); Symbiort (Formoterol/Budesonide); Brovana (Arformoterol); Perforomist (Formoterol) FDA reports that drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)

* Not currently marketed in the U.S.


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