The FDA now approves the drug Brisdelle (paroxetine) for the treatment of hot flashes, a symptom of menopause in women. In announcing its approval, the FDA Press Release noted that Brisdelle becomes the first treatment without hormones available to women. The first of its kind. The sequence of drug testing proved Brisdelle effective, but the FDA noted in its report that the true mechanism by which Brisdelle reduces hot flashes is not known . According to New York Times reporter, Andrew Pollack, an Advisory Committee to the FDA voted against approval of Brisdelle back in March. He thought it unusual that the FDA would go against their recommendation. Andrea Fischer, FDA Office of Media Affairs, noted in an email in response to this article that their recommendation is only one step in the approval process.
Many women are susceptible to hot flashes and suffer from it not wanting to use existing treatments containing hormones. The FDA notes current approved treatments contain estrogen with progestin or estrogen alone.
This new approval gives women help with an option not containing hormones. Testing, as always, occurred to make sure the drug was safe and effective. Nausea, vomiting, fatigue and headache were recorded. Brisdelle is a lower dose of the same drug ingredients in Pexeva and Paxil. Because of that, it will contain the same warning about an increase in risk of suicide in children and young adults. Other drug interaction warnings will be included. Any problems can be reported at 1-800-FDA-1088 or contact www.fda.gove/MedWatch under the MedWatch Adverse Event Reporting program.
By approving Brisdelle as a treatment for hot flashes, a symptom of menopause, the FDA stated that it is trying to respond to the demand for medical options other than hormone treatments. Andrea Fischer, of the FDA Office of Media Affairs, noted that the “FDA views paroxetine as a useful treatment option” when taken as directed. A full history of the approval process is available on the FDA website for review.