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Low dose paroxetine for menopausal hot flushes

19-May-2014

Against the advice of its Reproductive Health Drugs Advisory Committee, the US Federal Drugs Administration (FDA) has licenced the long established SSRI antidepressant paroxitene, in a 7.5mg formulation, for the treatment of menopausal hot flushes. The new low dose tablets will be marketed in the US under the name Brisdelle.   Presumably the FDA was influenced by two new randomised trials showing efficacy, but their advisory committee were worried about side effects. Some commentators have wondered if the new formulation/indication is a thinly veiled way to extend patent protection for this popular antidepressant.

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Commentaries by Editor Prof. Jim Thornton