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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

FDA reject rimonabant

The Food and Drugs Administration (FDA) is unlikely to licence rimonabant (Acomplia®) for the treatment of obesity after the advisory panel voted unanimously against recommending approval.

According to a report at PharmaTimes the panel were mainly concerned with psychiatric adverse effects, including suicide and seizures, seen in patients taking the drug. This led them to conclude that the benefits of treatment do not outweigh the risks.

As previously discussed, rimonobant occupies a last line option for treatment of obesity as an adjunct to diet and exercise. Additionally, MTRAC advised that use should be restricted and the DTB concluded that this drug was not a significant advance.

Action: In the light of this growing concern over safety and the lack of comparative efficacy data with existing treatment options it would seem prudent to make maximum use of existing therapies and to restrict use of rimonabant in existing patients only.

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One Comment to “FDA reject rimonabant”

  1. [...] a causal link. The WSJ also notes that rimonabant is not licensed in America, as previously reported, although an application is expected in 2009 as a treatment for Type 2 diabetes. Rimonabant is [...]

    Pingback by Prescribing Advice for GPs » WSJ links rimonabant to 5 UK deaths — June 9, 2008 #

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