FDA Approval of Paroxetine for Menopausal Hot Flushes

Ronald J. Orleans, Li Li, Myong-Jin Kim, Jia Guo, Mahboob Sobhan, Lisa Soule, Hylton V. Joffe

Index: N. Engl. J. Med. 370(19) , 1777-9, (2014)

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Abstract

An FDA advisory committee recommended against approving paroxetine for menopausal vasomotor symptoms. But recognizing the lack of hormone-free products for this indication, and after reviewing the drug's efficacy and safety, the FDA decided it can benefit some women. The recent approval by the Food and Drug Administration (FDA) of paroxetine (Brisdelle, Noven) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause was distinctive for at least two reasons. First, it offered the first nonhormonal option to women who cannot or do not want to use hormonal medications to treat their menopausal vasomotor symptoms. Second, the approval ran counter to the recommendation of the FDA Reproductive Health Drugs Advisory Committee, which had concluded, by a vote of 10 to 4, that the overall benefit–risk profile of Brisdelle did not support approval. The FDA always carefully considers the advice . . .