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FDA requests withdraw of sibutramine from U.S. market
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The FDA has issued a recommendation against the continued prescription and use of sibutramine due to elevated CV risks to certain patients taking the drug, according to a press release.
The agency determined that the CV risks outweighed the marginal benefits associated with the drugs and requested that the manufacturer of sibutramine (Meridia, Abbott Laboratories) voluntarily withdraw the product from the market in the U.S. Abbott Laboratories agreed to the request.
The withdraw came after new data from the approximately 10,000-patient Sibutramine Cardiovascular Outcomes (SCOUT) trial indicated a 16% increased risk for major adverse CV events (a composite of nonfatal MI, nonfatal stroke, resuscitation after MI and CV death) in patients taking sibutramine vs. placebo (HR=1.16; 95% CI, 1.03-1.31). The primary endpoint of the trial was driven, according to data cited in an FDA press release, by nonfatal MI (HR=1.28; 95% CI, 1.04-1.57) and nonfatal stroke (HR=1.36; 95% CI, 1.04-1.77).
The agency recommended in a press release that patients currently taking sibutramine cease taking the medication and consult their physicians about alternative weight loss management strategies and programs.
Sibutramine was approved by the FDA in 1997 for weight loss and maintenance of weight loss in patients with a BMI ≥30 kg/m2 or for patients with a BMI ≥27 kg/m2 with other CV risk factors. The FDA announced the continued review of clinical trial data regarding sibutramine in November 2009 and January 2010 due to reports of adverse effects on the heart following use of the drug.
The full FDA safety announcement can be viewed at: http://www.fda.gov/Drugs/DrugSafety/ucm228746.htm.
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