FDA rejects rimonabant due to psychiatric side effects

[Anasazi23]

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FDA panel unanimously rejects rimonabant. In continuing coverage from a previous briefing, the Wall Street Journal (6/14, A3, Corbett Dooren, Whalen) reports, "A Food and Drug Administration panel unanimously rejected Acomplia (rimonabant), a weight-loss drug from Sanofi-Aventis SA, on concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users." The Journal notes, "The decision is a blow to the Paris-based drugmaker, which is hoping to sell Acomplia on the U.S. market. ... The FDA is set to make a final decision on whether to approve Acomplia...by the end of July." Eric Colman, deputy director of the FDA's metabolic and endocrine drug product office, stated, "It was quite obvious there was serious concern about the safety profile of rimonabant," and noted that "the 14 voting members said additional safety information is needed before the FDA should consider approving the drug." The Journal also notes this story in its Health Blog (6/14, Goldstein).
CNN (6/14, Smith) notes, "The vote -- which specifically stated that the drug's risk does not outweigh its benefit -- is non-binding, but the agency's regulatory authorities usually take the advice of the advisors." Rimonabant is "already available in 10 European countries, as well as several other nations including Mexico."
The Los Angeles Times /AP (6/14, Bridges) adds, "In studies, patients given the once-daily tablet reported twice as many psychiatric side effects -- such as depression, anxiety and sleep problems -- as those who received dummy pills," Amy Egan, M.D., "an FDA medical officer, told federal health advisers. 'The numbers of events are small, but in aggregate they are worrisome,' she said."
USA Today (6/14) notes, "Egan said 88% of those reporting psychiatric problems while on the drug had no history of depression." However, Sanofi-Aventis "believes the psychiatric problems were tied to pre-existing conditions." Speaking for the company, Richard Gural said "the drug is not appropriate for anyone with a history of depression or suicidal thoughts, or who is taking antidepressant medication."
WebMD (6/14, Zwillich) reports that officials from Sanofi-Aventis "clashed with regulators over the size of the psychiatric risk, saying that thousand of patients who took the drug had suicide rates essentially identical to the general population. Sanofi-Aventis said they'd found a 30% increase in the risk of suicidal thoughts with the drug but that in studies those thoughts almost never led to suicide attempts." However, "FDA scientists countered with an analysis of 13 studies showing that the drug nearly doubled suicidal thinking while also doubling cases of anxiety, depression, and other mood disorders."
The CBS Evening News (6/13, story 11, 0:30, Couric) and HealthDay (6/14, Reinberg) also cover the story.

 

[OldPsychDoc]

Is it surprising that there would be psychiatric "side effects" when blocking a widely distributed receptor system (cannabinoids) with known psychoactive ramifications? 🙄

 

[whopper]

This IMHO is groundbreaking for us psychiatrists. I was closely following this med because I Was going to put money into SNY.

1-There could've been a huge upswell in psyche cases if Accomplia would've been approved in the US. I was anticipating it could've been like the new Viagra. Almost everyone would've bought some because almost everybody wants to lose some weight.

2-the fact that it has several psychiatric side effects calls into question the purpose of the receptor the med binds onto. Cannibas for example causes feelings of euphoria, munchies, relaxation, and blocking that receptor with this med appears to cause the opposite.

So far no agent in the body is known to bind onto this receptor and cause effect, however, given the side effects of Rimonabant this hypothetically calls into question that perhaps there is such a compound and perhaps someone out there could create a medication that exploits the use of the receptor.

It could lead to a new class of anti-anxiety, anti-nausea, weight gain/loss meds, utilizing a completely new drug pathway.

 

[Anasazi23]

This IMHO is groundbreaking for us psychiatrists. I was closely following this med because I Was going to put money into SNY.

Funny you say that. I'd been hemming and hawing on SNY also based on the potential success of this med. This steered me away from it for now. I might buy some later though.

 

[OldPsychDoc]

...
So far no agent in the body is known to bind onto this receptor and cause effect, however, given the side effects of Rimonabant this hypothetically calls into question that perhaps there is such a compound and perhaps someone out there could create a medication that exploits the use of the receptor.

Not quite true.
A readable review on cannabinoid receptors, with discussion of the endogenous ligands.

 

[whopper]

Thanks for the article! Didn't know about that!

Funny you say that. I'd been hemming and hawing on SNY also based on the potential success of this med. This steered me away from it for now. I might buy some later though.

Warren Buffet supposedly put in a lot of money into SNY on the same expectation. Now that the FDA will not give it approval, the stock as taken a significant hit.

Personally, that was the only strength I saw with SNY. Their 2 other main meds--ambien--is going to lose patent soon and they've had some legal battles with Plavix because someone started producing it as a generic and Sanofi is battling them in court.