The FDA recently approved paroxetine (which in higher doses is marketed as the antidepressant Paxil) as a nonhormonal treatment for hot flashes in menopausal women. The drug will be marketed as Brisdelle.
According to a New York Times article F.D.A. Approves a Drug for Hot Flashes, the approval was granted despite the fact that FDA’s own advisory committee voted 10 to 4 last March against approval.
The reported reason for the negative vote was that in clinical trials, Brisdelle proved only minimally effective.
Brisdelle apparently will be marketed with an “increased risk of suicidal thoughts and actions” label, but I wonder how many women who take the product will realize that they are taking a low dose of Paxil?