October 23, 2008

Anti-Obesity Drug Pulled From Market Due To Suicidality, Depression

Sanofi-aventis today announced that it was temporarily pulling Accomplia, its anti-obesity drug, from the market in Europe due to reports of side effects problems with the drug, including suicidality and depression. The drug has only been on the market in Europe a short time and is not approved for sale in the US.

From the BBC:

"There have always been concerns over the risks of depression and suicide associated with the drug, and in July last year, the EMEA warned it may be unsafe for patients also taking anti-depressants.

"Doctors were also told not to give it to patients with a history of major depression, and to be alert for new symptoms of depression in patients taking the drug. But data from more recent studies, and from Sanofi-Aventis itself, has shown there is around double the risk of psychiatric disorders in obese or overweight patients taking rimonabant compared to those taking dummy pills.

"And between June and August 2008, there were five suicides among patients taking part in a trial who were on the drug, compared with one among those taking the dummy version."

Five suicides in a clinical trial is a lot, even more so because the drug wasn't being trialed for a psychiatric condition. Makes you wonder what the drug's mechanism is that's uncorking all of this.

Posted by Philip Dawdy at October 23, 2008 11:39 AM
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Comments

They should take it from Brazilian market and I'm sure they still sell it on other countries.
But it's sold for whoever wants it online:
http://www.ultracontainers.com/

All other uses are off-label. Thus, your doctor can prescribe the medication for non-approved purposes or you can buy cheap Acomplia online and use it as you please. As a note of clarification, the fact that any medication is not formally approved by a regulatory body does not mean that it is in any way dangerous. It simply says that the manufacturer has not yet spent the money to get it approved.

Approved of not approved by FDA or MHRA is not safety guarantee! That's more absurd.

Sometimes I think we are all doing regulators agencies work.

Posted by: Ana at October 23, 2008 01:02 PM
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