Meridia sibutramine regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee split 8-8 on whether to withdraw anti-obesity drug Meridia sibutramine from Abbott from the U.S. market. While 8 panel members felt that the drug should be pulled from the market, 6 recommended that Meridia remain on the market with a restricted distribution system and label changes, including a boxed warning. Two panelists voted that only the label changes were necessary. No one voted to keep Meridia on the market without additional label changes or restrictions.

The panel's decision was based on the results of the post-marketing SCOUT trial in which Meridia was associated with a significantly higher rate of primary cardiovascular outcomes vs. placebo in overweight or obese patients with pre-existing cardiovascular disease and/or Type II diabetes (see BioCentury, Sept. 13). The trial was started in 2003 at the request of European regulators. ...