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.
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.
FDA adds boxed warning to fezolinetant for rare serious liver injury
Published: December 17th 2024 | Updated: December 17th 2024The FDA has added a boxed warning for fezolinetant (VEOZAH; Astellas), highlighting the rare occurrence of serious liver injury in patients taking the menopause treatment.
Read More
Shared genetics found between anti-Müllerian hormone and age at menopause
December 4th 2024In a recent study, an inverse relationship was discovered between anti-Müllerian hormone levels and early menopause, highlighting the need to develop interventions for fertility preservation based on genetics.
Read More
