FDA Approves Nonhormonal Drug for Hot Flashes: Low-Dose Paroxetine to be Marketed as Brisdelle

FDA Approves Nonhormonal Drug for Hot Flashes: Low-Dose Paroxetine to be Marketed as Brisdelle

The FDA recently approved a 7.5-mg formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate for the treatment of hot flashes.   It will be marketed under the name of Brisdelle.
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The FDA recently approved a 7.5-mg formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate for the treatment of hot flashes.   It will be marketed under the name of Brisdelle.

It should be noted that while not yet approved by the FDA for this indication, other SSRIs and SNRIs (such as Effexor) may be as effective as Brisdelle.  Importantly, paroxetine may reduce the efficacy of tamoxifen; Brisdelle should therefore not be used in women taking tamoxifen.

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Ruta Nonacs, MD PhD

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