Patients  
  & Visitors  
  Services &  
  Procedures  
Login/Join Community
Careers & Employment Volunteers Online Bill Pay Contact Us Concierge 1700 S. Tamiami Trail, 34239 • Phone: (941) 917-9000

First Non-Hormonal Remedy Approved for Menopausal Hot Flashes

Printer Friendly Version Printer Friendly Version
Share

Jul/11/2013

HealthDay News -- Brisdelle (paroxetine) has been approved by the U.S. Food and Drug Administration as the first non-hormonal treatment to treat hot flashes associated with menopause.

All prior FDA-approved drugs for hot flashes contain either the hormone estrogen alone or the hormonal combination of estrogen and progestin, the agency said in a news release.

Brisdelle's active ingredient is paroxetine, in a smaller amount than the same active ingredient in the antidepressant Paxil. It's not understood how paroxetine treats hot flashes, the FDA said.

Hot flashes affect up to 75 percent of all women, and can linger for as long as five years. Briselle's safety and effectiveness in treating the condition were evaluated in clinical studies involving 1,175 post-menopausal women with moderate-to-severe hot flashes. The most common side effects of the once-daily drug were headache, fatigue and nausea/vomiting.

Paroxetine, a selective serotonin reuptake inhibitor (SSRI), has the same boxed label warning as other antidepressant drugs in its class. The label warns of possible increased risk of suicide among children and young adults.

Brisdelle's label also warns of a possible reduction in the effectiveness of tamoxifen -- a drug prescribed to treat breast cancer -- if both medications are taken together. Other potential serious side effects include increased risk of bleeding and developing a condition called serotonin syndrome, the FDA said.

Brisdelle is marketed by Noven Therapeutics, based in Miami, Fla.

More information
To learn more about this approval, visit the FDA.

Health NewsCopyright © 2013 HealthDay. All rights reserved.
The information in this article, including reference materials, are provided to you solely for educational or research purposes. Information in reference materials, are not and should not be considered professional health care advice upon which you should rely. Health care information changes rapidly and consequently, information in this article may be out of date. Questions about personal health should always be referred to a physician or other health care professional. 

Reporting Concerns | PRIVACY POLICY | Terms of Service | Online Bill Pay | Mobile Site | Smartphone App
Site optimized for Chrome or Firefox | Copyright © 2014. Sarasota Memorial Health Care System. All rights reserved.