Diet Pill Acomplia Safety Concerns To Be Aired by FDA Advisory Panel in June
Safety concerns that have been raised about diet pill rimonabant (Acomplia / Zimulti) will get a full airing before an independent FDA advisory panel in June prior to any agency action on whether to approve the diet drug for sale in the United States.
Sanofi-Aventis announced on March 26th that the pros and cons of the highly anticipated obesity drug would reviewed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee at a meeting scheduled for June 13th.
With a number of studies fairly clearly documenting that Acomplia can facilitate signficant weight loss in the first year of use, as well as improve other cardiometabolic risk factors such as cholesterol, discussion at the June 13th meeting seems certain to center on safety issues.
The diet pill is the first in a class of drugs that operates by blocking CB-1 receptors in the brain, and has been linked to depression and other psychotic side effects.
"Sanofi-Aventis is pleased to have the opportunity to present its data on rimonabant and to exchange with experts," Sanofi said in a statement confirming the FDA advisory panel hearing.
While rimonabant is already on sale in a number of Europe countries as well as Mexico and Argentina as rimonabant, the likelihood is that if approved in the U.S. it will be marketed as Zimulti.
Sanofi announced earlier this year that the FDA had added another three months to its review of the drug to consider additional data, delaying any decision to the end of July.
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