The Medical Letter on Drugs and Therapeutics
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In Brief: Sibutramine (Meridia) Withdrawn
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 Select a term to see related articles  2010   Drug Safety   Meridia   Sibutramine   Weight loss 

The results of a postmarketing study of its cardiovascular safety have led to the removal of the weightloss drug sibutramine (Meridia) from the market in the US and Canada. It has also been withdrawn in Europe and Australia, but remains on the market in many other countries. The study that led the FDA to ask Abbott Laboratories to withdraw the drug randomized 10,744 overweight patients with cardiovascular disease, diabetes or both to sibutramine or placebo for a mean duration of 3.4 years. The primary endpoint (non-fatal myocardial infarction, nonfatal stroke, cardiovascular death or resuscitation after cardiac arrest) occurred in 561 of 4906 patients (11.4%) taking sibutramine and in 490 of 4898 (10%) taking placebo (p = 0.02). Death from any cause occurred in 8.5% of the patients who took sibutramine and in 8.2% of those on placebo; this difference was not statistically significant.1

1. WP James et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med 2010; 363:905.

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