First Non-Hormonal Treatment for Hot Flashes Approved by FDA

In an unexpected move, the FDA approved Brisdelle (paroxetine), the first non-hormonal treatment for hot flashes associated with menopause, in spite of a recent panel’s recommendation against the drug.

Brisdelle contains 7.5 mg of paroxetine, a selective serotonin reuptake inhibitor (SSRI) that is used at higher doses to treat depression and anxiety disorders. Two randomized, controlled, double-blind studies in women with moderate to severe hot flashes showed that Brisdelle reduced the frequency and severity of hot flashes.

There was a low occurrence of side effects, most commonly nausea. Because paroxetine is also used to treat depression, it will carry a Boxed Warning about the possibility of the medication increasing suicidality in children and young adults.

Hot flashes affect nearly 75% of women in menopause. Historically, hormone therapy with estrogen has been the only approved pharmacologic treatment, but its side effects and risk profile made it unacceptable for many patients.