January 22, 2010

FDA Issues Alert on Weight-Loss Drug Meridia

On January 21, 2010 the FDA issued a warning to healthcare professionals regarding the weight-loss drug Meridia (Abbott Laboratories). The warning comes after a review of additional data from a trial known as SCOUT showed an increased risk of heart attack and stroke among patients taking Meridia who have a history of cardiovascular disease. Based on the serious nature of the review findings, the FDA requested and the manufacturer agreed to add a new contraindication to the Meridia (sibutramine) drug label stating that Meridia is not to be used in patients with a history of cardiovascular disease, including:

  • History of coronary artery disease (e.g., heart attack, angina) 
  • History of stroke or transient ischemic attack (TIA) 
  • History of heart arrhythmias 
  • History of congestive heart failure 
  • History of peripheral arterial disease 
  • Uncontrolled hypertension (e.g., > 145/90 mmHg)

Many consumer advocacy groups including Public Citizen have strongly petitioned the FDA to pull Meridia from the market deeming the drug unsafe and urging the FDA to follow the example of the European Medicines Agency who have banned the drug.  U.S. patients currently using Meridia should talk with their healthcare professional to determine if continued use of Meridia is appropriate and discuss any questions they may have about their treatment.

Click here to read FDA Safety Information

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