Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

Changes to the Warnings Sections of Norpramin (desipramine) Prescribing Information
Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings section of the Prescribing Information for Norpramin (desipramine) regarding the risk of heart problems and seizures. These updated warnings now state: 1) In general, Norpramin should be used with extreme caution in patients with heart disease because of the possibility of conduction defects, arrhythmias (abnormal heart rhythms), tachycardias (fast heart rate), strokes, and acute myocardial infarction. The updated safety information now also warns that extreme caution should be used when this drug is given to patients who have a family history of sudden death, arrhythmias, and cardiac conduction disturbances. 2) Norpramin has been shown to lower the seizure threshold and should be used with extreme caution in patients with a history of seizures. The updated prescribing information now warns that seizures have occurred before arrythmias and death in some patients who have used Norpramin. Norpramin is indicated for the treatment of depression. These new warnings also apply to desipramine, the generic name for Norpramin. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm
Learn More

FDA Early Communication About Ongoing Safety Review of Sibutramine (Meridia)
The FDA has announced an ongoing safety review of sibutramine (marketed as Meridia), a medicine used in the management of obesity. Early results from a recent study suggest that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). The study, named the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT), began in 2002. Patients included in the study were 55 years of age or older, overweight or obese, and had a history of heart disease or type 2 diabetes plus one additional cardiovascular risk factor. The early study results show that cardiovascular events were reported in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference is higher than expected and suggests that sibutramine is associated with an increased cardiovascular risk in the study population. The analysis of these results is ongoing and the FDA is making no conclusions about these early findings at this time. The FDA will communicate its findings to the public as soon as this review is complete. For more information, please visit, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm191650.htm
Learn More

Date Published Title Drug Source
2009-12-03 Changes to the Warnings Sections of Norpramin (desipramine) Prescribing Information Desipramine FDA
2009-11-23 FDA Early Communication About Ongoing Safety Review of Sibutramine (Meridia) Sibutramine FDA
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Oxymetazoline FDA
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Phenylephrine FDA
2009-11-20 Recall on A Single Lot of OPANA ER (Oxymorphone) 10 mg Extended Release Tablets Oxymorphone FDA
2009-11-20 Recall of Single Lot of Advanced Listerine with Tartar Protection Listerine FDA
2009-11-20 Recall of a Single Lot of Ranbaxy Sotret (Isotretinoin) 40 mg Capsules Isotretinoin FDA
2009-11-20 Recall of a Single Lot of Teva / Ivax Oxazepam 15 mg Capsules Oxazepam FDA
2009-11-20 Recall of Several Lots of Brompheniramine Tannate Suspension Brompheniramine FDA
2009-11-20 Recall of a Single Lot of Brompheniramine Phenylephrine Tannate Suspension Brompheniramine with Phenylephrine FDA
2009-11-17 Updated Safety Information About A Drug Interaction Between Clopidogrel (Plavix) and Omeprazole (Prilosec, Prilosec OTC) Clopidogrel FDA
2009-11-14 Possible Contamination of Thyrogen Thyrotropin Alfa FDA
2009-11-14 Possible Contamination of Aldurazyme Laronidase FDA
2009-11-14 Possible Contamination of Myozyme Alglucosidase Alfa FDA
2009-11-14 Possible Contamination of Fabrazyme Agalsidase Beta FDA
2009-11-14 Possible Contamination of Cerezyme Imiglucerase FDA
2009-11-12 Recall on a Single Lot of Invega Extended Release 6 mg Tablets Paliperidone FDA
2009-11-12 Recall on a Single Lot of Temodar Capsules 5 mg Temozolomide FDA
2009-11-12 Recall on Several Lots of Teva / Novopharm Clonazepam 0.5 mg and 1 mg Tablets Clonazepam FDA
2009-11-04 FDA Answers Common Questions About Relenza Zanamivir FDA