Weight Loss Drug Acomplia Yanked from Market Over Psychiatric Risks

With the psychiatric side effects of rimonabant (sold as Acomplia in Europe and as Zimulti elsewhere) turning out to be even worse than originally thought, and the effectiveness of this new weight loss drug turning out to be pretty minimal, Sanofi-Aventis has yanked it from the market following a decision by European regulators to suspend marketing approval.

A note sent to physicians a few days ago indicates that the European Medicines Agency (EMEA) has concluded the risks of rimonabant outweigh its benefits and gives the following advice:

  • Prescribers should not issue any prescriptions for rimonabant, and should review the treatment of those who are currently taking this medicine.
  • Patients who are currently taking rimonabant should consult their doctor or pharmacist at a convenient time to discuss their treatment. If patients wish to stop taking rimonabant, it is safe to do so at any time.
  • Patients who are currently enrolled in clinical trials of rimonabant may wish to contact the trial investigator (the doctor who is treating them), who will be able to give more information. Trial investigators are being notified of this suspension of the marketing authorisation.

The risk of psychiatric complications — including anxiety, depression and suicidality — associated with the use of Acomplia has been widely reported (see ). But in real world use, it turned out that the incidence of adverse side effects was even higher than it was in clinical trials — with roughly double the risk of adverse psychiatric reaction with Acomplia use as compared to placebo. In real world use, where patients may take the drug for only a relatively short period of time, it also turned out the effectiveness of Acomplia was pretty minimal.

Another new anti-obesity drug, taranabant, was rejected just a few weeks ago by the Food and Drug Adminstration, with Merck deciding to cancel further investigation into the experimental drug because of psychiatric side effects exposed during clinical trials.

All clinical material on this site is peer reviewed by one or more clinical psychologists or other qualified mental health professionals. This specific article was originally published by on and was last reviewed or updated by Dr Greg Mulhauser, Managing Editor on .

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