FDA Approves a Dangerous New Antidepressant—for Hot Flashes!

The FDA has approved the first non-hormonal treatment for hot flashes associated with menopause. The drug is paroxetine mesylate (marketed as Brisdelle). Paroxetine, an SSRI, is the active ingredient in two drugs for depression and other psychiatric disorders, Paxil and Pexeva. What is not mentioned is that the FDA’s Reproductive Health Drugs Advisory Committee voted 10 to 4 that the overall risk-benefit profile of the drug did not support approval—that the benefits over placebo were “minimal,” and that all of the severe side effects associated with SSRIs, such as suicidal thoughts and osteoporosis, outweigh the minor benefits.