Weight Loss Drug Withdrawn from Market Because of Harmful Effects

FDA has announced the withdrawal of sibutramine, a weight loss drug, from the market because recent studies showed increased risk of stroke and myocardial infarction in its use.

The Sibutramine Cardiovascular Outcome Trial (SCOUT), a post marketing research study showed that the weight loss drug which was approved for use in the market in 1997 increased the risk of serious cardiovascular complications compared to placebo. The results of the study were published in the Sept 2, 2010 issue of the New England Journal of Medicine. More than 10,000 overweight or obese men and women over the age of 55 with pre-existing cardiovascular disease and/or diabetes participated in the study. They were randomized, took either sibutramine or placebo and were followed up for around 3 years.


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