Alerts
Sibutramine Hydrochloride (Meridia) Withdrawn from Market Due to Increased Risk of Cardiovascular Events
October 11, 2010
Abbott Laboratories has initiated a voluntary withdrawal of Meridia (sibutramine hydrochloride) due to the increased risk of cardiovascular events. In November 2009, FDA began a review of safety data concerning cardiovascular events with sibutramine. Postmarketing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT) of approximately 10,000 patients revealed a 16% increase in the risk of heart attack, stroke, and death in patients given sibutramine compared to placebo.
Healthcare providers should stop prescribing sibutramine to patients. Patients taking sibutramine for the management of weight loss should stop taking the medication and talk with their healthcare providers about alternative treatment approaches. Pharmacies and wholesalers should return unused product to Abbott Laboratories.
Additional information is available at the following links:
- MedWatch Alert:
- October 2010
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm228830.htm - January 2010
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm198221.htm - November 2009
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm191655.htm - FDA Drug Safety Communication:
http://www.fda.gov/Drugs/DrugSafety/ucm228746.htm - FDA Q&A Sibutramine:
http://www.fda.gov/Drugs/DrugSafety/ucm228747.htm - FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm228812.htm - Follow-up to the Early Communication of Ongoing Safety Review:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm - Early Communication About an Ongoing Safety Review:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm191650.htm
Updated
October 8, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
