So Much for Big Pharma's 'Anti-Pot' Pill
By Paul Armentano, AlterNet. Posted June 15, 2007.
The FDA has rejected a controversial diet aid that is supposed to counteract the effects of pot and has been linked to suicidal thoughts and depression.An independent U.S. Food and Drug Administration advisory committee determined yesterday that the controversial "anti-pot" pill Rimonabant is unsafe for human consumption in the United States. Sanofi-Aventis' would-be diet aid -- which has been linked to suicidal thoughts, depression and even multiple sclerosis -- counteracts the effects of marijuana and similar naturally occurring chemicals in the body (so-called endocannabinoids), causing users to lose their appetites and, according to the warnings of experts, a host of other unwanted and dangerous side effects.
Rimonabant does not possess a "favorable risk-benefit profile" to warrant U.S. market approval, members of the FDA's Endocrinologic and Metabolic Drug advisory panel determined in a 14-0 vote. Panelists reported that patients prescribed Rimonabant experienced increased incidences of depression, nausea, vomiting, and suicidal tendencies. Adverse neurological symptoms in some patients were also reported.
The expert panel's rejection sent shares of Sanofi stock plummeting and may have worldwide implications. Last summer European regulators gave preliminary approval to the pill, which has now been prescribed to some 100,000 patients under the trade name Acomplia. However, following Wednesday's unanimous decision, representatives of the European Medicines Agency immediately announced that they will begin hearings to consider recalling the drug.
For Sanofi stockholders and analysts, who had predicted that pharmaceutical giant's "anti-pot" pill could one day rake in some $3 billion in annual profits, the news is a disappointing financial setback. But to health experts familiar with the workings of Rimonabant and similar drugs, the FDA panel's decision comes as little surprise and is long overdue. ......(more)
The complete piece is at:
http://www.alternet.org/drugreporter/54191/