Thursday, June 14, 2007

FDA Advisory Panel Says Controversial Cannabinnoid Blocker Not Safe For Human Consumption

Thank you to NORML for this. I apologize for yet ANOTHER take on this same story. This one however, is from a cannabinoid receptor antagonist perspective. When I first heard the academic medical talk on this nasty harmful synthetic molecule, it made me want to go running from the auditorium. I stayed to listen to the cute, young and earnest researcher present her data from a study using this antagonist for college students who wanted to "quit pot."

I asked her if she didn't think that smoking pot was a normal social part of the college experience, much like drinking at frat parties? She said," well yes."

I asked her how does she determine if an individual needs to consider this type of extreme treatment? There was obviously no thought given to this issue other than "meeting DSM-4R criteria for Marijuana Abuse or Dependence."

Give me a break and a toke... my golly gee whiz.

Rockville, MD: An independent Food and Drug Administration (FDA) advisory committee determined on Wednesday that the controversial cannabinoid receptor antagonist Rimonabant (also known as Acomplia) is unsafe for human consumption in the United States. The drug's manufacturer, Sanofi-Aventis Pharmaceuticals, is seeking FDA approval to market the drug in the US as a dietary aid.

Members of the FDA's Endocrinologic and Metabolic Drug advisory panel resolved 14-0 that the drug did not possess a "favorable risk-benefit profile" to warrant US regulatory approval. Panelists reported that patients prescribed Rimonabant experienced increased incidences of depression, nausea, vomiting, and suicidal tendencies. Adverse neurological symptoms, including multiple sclerosis, have also been documented in subjects who have taken Rimonabant.

European regulators previously approved the prescription use of Rimonabant, marketed under the trade name Acomplia, in 2006 but are now expected to review their decision. Rimonabant is the first cannabinoid antagonist ever to be approved for human consumption. More than 100,000 European patients have been prescribed Acomplia since its approval last year.

The FDA is expected to make a final ruling regarding whether to approve or reject the drug in July. The agency typically abides by the recommendations of its advisory panels, but it is not legally required to do so.

Rimonabant blocks the natural binding of endogenous cannabinoids (as well as exogenous cannabinoids such as THC) to the neuronal CB1 receptors, causing users to lose their appetites. However, because the endocannabinoid receptor system is intricately involved in the regulation of a broad range of primary biological functions – including appetite, body temperature, mood regulation, blood pressure, bone density, reproduction, learning capacity, and motor coordination – some experts are concerned that the long-term use of Rimonabant or similar drugs may contribute to a host of significant adverse health effects.

In preclinical trials, newborn mice injected with Rimonabant refuse feeding and often die days after birth. Mice genetically bred to lack the CB1 receptor also suffer from numerous health defects such as cognitive decline, hypoalgesia, decreased locomotor activity, and increased mortality compared to healthy controls.

At least one published case study reports that daily use of the drug may have triggered neurological symptoms of multiple sclerosis in a volunteer with no known history of the disease. Mental health side effects, such as depression, are also commonly reported among volunteers administered Rimonabant. FDA panelists reported that using Rimonabant nearly doubled the users risk of attempting suicide.

The FDA has previously rejected requests by Sanofi-Aventis to approve the drug as a smoking cessation agent.

For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at:

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