Abbott withdraws obesity drug voluntarily

Published: 11-Oct-2010
Regulatory

Clinical trial data indicated an increased risk of heart attack and stroke


Abbott Laboratories has agreed to withdraw voluntarily its obesity drug Meridia (sibutramine) from the US market because of clinical trial data indicating an increased risk of heart attack and stroke, according to the US Food and Drug Administration.

Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5% of their body weight than those on placebo who relied on diet and exercise alone.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug.

The trial demonstrated a 16% increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

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