WASHINGTON, Oct. 8 (UPI) — Abbott Laboratories says it will voluntarily withdraw obesity drug Meridia from the U.S. market at the request of the U.S. Food and Drug Administration.
The FDA’s request is based primarily on the results of an approximately 10,000-patient, six-year study requested by European regulatory authorities to evaluate cardiovascular safety in high-risk patients, an Abbott release said Friday.
The voluntary withdrawal of sibutramine (Meridia) in the U.S. follows an 11-month process, beginning in November 2009, when Abbott notified the FDA of the preliminary results of the study.
The European Medicines Agency suspended marketing authorization for all anti-obesity medicines containing sibutramine in January 2010.
On Sept. 15, a public advisory panel with 16 experts selected by the FDA split 8-8 on a decision about Merida, with eight advisers voting in favor of enhanced labeling and risk management activities compared with eight advisors in favor of withdrawal.
Abbott said it believes sibutramine has a positive risk/benefit profile in the approved patient population but will comply with the FDA’s request, the company release said.
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