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What's Old Is New Again: Paroxetine for Hot Flashes?

News in Context |
July 8, 2013

What's Old Is New Again: Paroxetine for Hot Flashes?

  1. Anne Moore, DNP, APRN, FAANPAU1964

FDA approves first nonhormonal menopausal therapy.

  1. Anne Moore, DNP, APRN, FAANPAU1964

On June 28, 2013, the FDA approved a 7.5-mg formulation of paroxetine mesylate (Brisdelle) for treatment of moderate to severe menopausal hot flashes. Recommended dosing is one 7.5-mg oral capsule daily at bedtime.

To assess efficacy and safety, researchers conducted two randomized, double-blind, placebo-controlled trials in a total of 1175 women who reported experiencing at least 7 to 8 moderate-to-severe hot flashes daily. Brisdelle reduced daily hot flash frequency more than placebo: The difference between the median changes from baseline was 1 to 2 hot flashes daily. The mechanism of action for alleviating hot flashes remains unknown.

Comment

Paroxetine is a selective serotonin reuptake inhibitor that has been used at higher doses for treatment of generalized anxiety disorder, major depressive disorder, obsessive-compulsive disorder, and other psychiatric conditions. Despite its lower dosing in Brisdelle, this medication is not without side effects (e.g., nausea, headache, fatigue) and warnings (suicidality). Although it represents an important nonhormonal option for diminishing hot flashes, how beneficial this drug will be in practice remains to be seen.

Dr. Andrew Kaunitz, Editor-in-Chief of NEJM Journal Watch Women's Health, was an investigator for one of the Brisdelle trials but had no role in writing or editing this News in Context.

  • Disclosures for Anne Moore, DNP, APRN, FAANP at time of publication Consultant / Advisory board Watson

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Reader Comments (1)

GREENSTEIN, GARY MD Physician, Obstetrics/Gynecology, office

concise and helpful

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