FDA Goes Against Its Advisory Panel
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. ...