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Abbott Laboratories is withdrawing the weight-loss drug sibutramine (Meridia) from the U.S. market because it poses an increased risk for heart attack and stroke.
The FDA requested the withdrawal after completing its September 2010 review of data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). In SCOUT, patients with cardiovascular disease or diabetes who were given sibutramine had a 16% increased risk for serious CV events, compared with those given placebo.
The agency says that physicians should stop prescribing sibutramine and contact patients currently taking the drug. In addition, adverse events should be reported to the MedWatch program.
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LINK(S):
FDA MedWatch alert (Free)
MedWatch program (Free)
Physician's First Watch coverage of SCOUT (Free)