FDA Approves Non-Hormonal Menopause Drug

5:37 PM, Jul 1, 2013   |    comments
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WASHINGTON (WUSA9) -- Hot flashes have been known to become one of menopause's infamously irritating symptoms. But the FDA has just approved a new treatment. The drug known as Brisdelle has become the first non-hormonal drug to beat menopause-associated hot flashes. 

Brisdelle is offically known as paroxetine mesylate and includes Paroxentine, a selective serotonin reuptake inhibitor (SSRI). It is also the active ingredient in the anti-depressants Paxil and Pexeva.

"There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments," stated Hylton Joffe, M.D., director of the Bivision of Bone, Reproductive, and Urologic Products in the FDA's Center for Drug Evaluation and Research.

 The FDA states that Brisdelle was proven safe and effective in two clinical trials and in those trials, it was noted that headaches, nausea, and vomiting were the most common side effects.  

There is also a warning on the drug's label about an increased risk for committing suicide, a warning found on similar medicatins that are SSRI's. There is also an additional warning that the drug might decrease the effectiveness of tamoxifen, a breast cancer drug, if they are taken at the same time.


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