2011 Drug Safety Communications
- Acetaminophen - Addition of another concentration of liquid acetaminophen marketed for infants 12/22/2011
- Gilenya - Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod) 12/20/2011
- Multaq - Review update of Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events 12/19/2011
- Zocor (simvastatin) - Revised dose limitation for Zocor (simvastatin) when taken with amiodarone 12/15/2011
- SSRI - Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies 12/14/2011
- ADHD - Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults 12/12/2011
- Pradaxa - Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) 12/07/2011
- Nplate and Promacta - Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag) 12/06/2011
- Trilipix - Review update of Trilipix (fenofibric acid) and the ACCORD Lipid Trial 11/09/2011
- Avandia (rosiglitazone) - Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program 11/04/2011
- TNF Blockers - UPDATE on Tumor Necrosis Factor (TNF) blockers and risk for pediatric malignancy 11/03/2011
- ADHD - Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults 11/01/2011
- Drospirenone - Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone 10/27/2011
- Xigris [drotrecogin alfa (activated)] - Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit 10/25/2011
- Chantix (varenicline) - Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events 10/24/2011
- Linezolid (Zyvox) - Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications 10/20/2011
- Methylene Blue - Updated information about the drug interaction between methylene blue (methylthioninium chloride) and serotonergic psychiatric medications 10/20/2011
- Sprycel - Sprycel (dasatinib) and risk of pulmonary arterial hypertension 10/11/2011
- Drospirenone - Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone 09/26/2011
- Zofran (ondansetron) - Abnormal heart rhythms may be associated with use of Zofran (ondansetron) 09/15/2011
- Tumor Necrosis Factor-alpha - Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria 09/07/2011
- Saphris (asenapine maleate) - Serious allergic reactions reported with the use of Saphris (asenapine maleate) 09/01/2011
- Reclast (zoledronic acid) - New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid) 09/01/2011
- Celexa (citalopram hydrobromide)- Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide) 08/24/2011
- Actos (pioglitazone) - Updated drug labels for pioglitazone-containing medicines 08/04/2011
- Somatropin - Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death 08/04/2011
- Diflucan - Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants 08/03/2011
- Linezolid (Zyvox) - Serious CNS reactions possible when linezolid (Zyvox) is given to patients taking certain psychiatric medications 07/26/2011
- Methylene Blue - Serious CNS reactions possible when methylene blue is given to patients taking certain psychiatric medications 07/26/2011
- CardioGen-82 - FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients 07/26/2011
- Chantix (varenicline) drug label now contains updated efficacy and safety information 07/22/2011
- Multaq (dronedarone) and increased risk of death and serious cardiovascular adverse events 07/21/2011
- Bisphosphonates - Ongoing safety review of oral osteoporosis drugs (bisphosphonates) and potential increased risk of esophageal cancer 07/21/2011
- CardioGen-82 - Increased radiation exposure due to undetected strontium breakthrough when using CardioGen-82 for cardiac positron emission tomography (PET) scans 07/15/2011
- Tamiflu - Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension 07/11/2011
- Valproate - Children born to mothers who took Valproate products while pregnant may have impaired cognitive development 06/30/2011
- ESAs - New dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease 06/24/2011
- Chantix - Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease 06/16/2011
- Actos - Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer 06/15/2011
- Risperdal and Requip - Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip) 06/13/2011
- 5-ARIs - 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer 06/09/2011
- Simvastatin - New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury 06/08/2011
- Angiotensin Receptor Blockers - No increase in risk of cancer with certain blood pressure drugs 06/02/2011
- Drospirenone - Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone 05/31/2011
- Rosiglitazone - Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl 05/18/2011
- Glass Syringe - Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone 05/06/2011
- Tysabri - Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab) 04/22/2011
- LABA - FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs) 04/15/2011
- TNF Blockers - Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine 04/14/2011
- Olmesartan - Safety Review Update of Benicar (olmesartan) and cardiovascular events 04/14/2011
- Revlimid - Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies 04/08/2011
- Benzocaine sprays - FDA continues to receive reports of serious and potentially fatal adverse effects with the use of benzocaine sprays for medical procedures 04/07/2011
- Benzocaine gels and liquids - Reports of serious and potentially fatal adverse effects with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth 04/07/2011
- Pradaxa (dabigatran etexilate mesylate) - Patients and healthcare professionals must follow special storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules 03/29/2011
- PPI Update - Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors 03/23/2011
- Kaletra - Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution 03/08/2011
- Letairis - Liver injury warning to be removed from Letairis (ambrisentan) tablets 03/04/2011
- Topamax - Risk of oral clefts in children born to mothers taking Topamax (topiramate) 03/04/2011
- PPIs - Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs (PPIs) 03/02/2011
- Abacavir - Safety Review update of Abacavir and possible increased risk of heart attack 03/01/2011
- Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns 02/22/2011
- Terbutaline - New warnings against use of terbutaline to treat preterm labor 02/17/2011
- Avandia - Avandia (rosiglitazone) labels now contain updated information about cardiovascular risks and use in certain patients 02/03/2011
- Multaq (dronedarone) - Severe liver injury associated with the use of dronedarone (marketed as Multaq) 01/14/2011
- Acetaminophen - Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure 01/13/2011
- Lantus - Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer 01/12/2011