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FDA approves hot-flash drug

9:40 AM, Jun 29, 2013   |    comments
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By: Tim Wilemon, The Tennessean

The U.S. Food and Drug Administration Friday approved the first non-hormonal medicine to treat hot flashes associated with menopause.

The drug, Brisdelle, contains the selective serotonin reuptake inhibitor paroxetine mesylate. Other FDA-approved treatments for hot flashes contain either estrogen alone or estrogen plus progestin.

Hot flashes occur in up to 75 percent of women during menopause and can persist for up to five years, or even longer in some women.

"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," said Dr. Hylton V. Joffe with the FDA's Center for Drug Evaluation and Research.

The most common side effects in patients treated with Brisdelle were headache, fatigue and nausea/vomiting.

Brisdelle contains a lower dosage of paroxetine, which, in a higher dose, is an active ingredient in the anti-anxiety drug Paxil. Brisdelle's side effects include a possible reduction in the effectiveness of tamoxifen if both medications are used together.

Brisdelle and Pexeva are marketed by Noven Therapeutics LLC, based in Miami. Paxil is marketed by Philadelphia-based GlaxoSmithKline.

Contact Tom Wilemon at or 615-726-5961.

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