Brisdelle Approved by FDA for Hot Flashes in Women
Back in March of this year, a medical report was published stating an FDA advisory panel had determined that antidepressants (namely a drug called gabapentin) and anti-anxiety medications were not an effective treatment for women suffering with hot flashes and night sweats in perimenopause and menopause, citing there was not enough evidence to show if the “benefits outweighed the risks.”
I wrote about the report here.
The FDA has now approved the use of Brisdelle. The drug (which is actually paroxetine, a generic medication), has been used for years among OB-GYNs to treat symptomatic hot flashes.
Paroxetine has also been prescribed as the antidepressant drug Paxil; the FDA has approved Brisdelle, which contains a lower, 7.5 milligram dose, in order to provide women with a “non-hormonal alternative” to treat hot flashes and night sweats.
According to Dr. Tara Shirazian, a gynecologist at Mount Sinai Hospital in New York, “the FDA advisory panel likely disapproved of the drugs before because the scientific data -- on which the panel relies -- was likely not compelling enough.” Brisdelle is said to decrease the intensity and frequency of hot flashes, and will now be marketed as an alternative to women who cannot or do not wish to use hormones to treat perimenopause symptoms.
And that’s that, ladies. While you might find these never ending conflicting medical reports as irritating as I do, as a women’s health writer, I feel an obligation to at least let you know what information is out there.
My opinion and recommendations remain the same: take the meat, spit out the bones, and make the best healthcare decision for you that you can, based on the best information available.
And don’t shoot the messenger.
Magnolia Miller is a certified healthcare consumer advocate in women's health and a women's freelance health writer and blogger at The Perimenopause Blog.
December 17, 2013: This blog post has been updated to correct an error. An earlier version referred to Brisdelle as an antidepressant medication. While the active ingredient in Brisdelle is prescribed to treat depression, Brisdelle itself is not an antidepressant.