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Drug for low sexual desire carries significant harms, FDA advisers find

BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c3339 (Published 07 July 2010) Cite this as: BMJ 2010;341:c3339
  1. Ray Moynihan
  1. 1Byron Bay, New South Wales

    A committee of advisers to the US Food and Drug Administration has unanimously rejected an application to approve the drug flibanserin for low sexual desire in premenopausal women.

    Last month an 11 member advisory committee found that flibanserin’s manufacturer, Boehringer Ingelheim, had failed to show overall efficacy for its drug, which caused worrying side effects, including dizziness, fainting, and accidental injury, leading to almost one in seven women dropping out of clinical trials.

    Final approval rests with the FDA, although it is considered unlikely to overturn its advisers’ unanimous rejection.

    An experimental drug that affects neurotransmitters, including serotonin, flibanserin previously failed in trials as …

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