FDA Approves Non-Hormonal Drug For Hot Flashes During Menopause

The Unites States Food and Drugs Administration has approved the first non-hormonal drug to treat hot flashes associated with menopause.

The U.S. Food and Drugs Administration has approved the first non-hormonal drug to treat hot flashes associated with menopause. The drug, Brisdelle (paroxetine), contains the selective serotonin reuptake inhibitor paroxetine mesylate and can be used to treat moderate to severe hot flashes experience by women during menopause.

Hot flashes during menopause are known to affect 75 percent of women worldwide. According to a FDA press release, though this condition is not fatal it can carry on for five or more years in some women causing a lot of discomfort and disrupted sleep.

"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 Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. "Today's approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause.

The drug safety was tested through two experiments on 1,175 postmenopausal women with moderate to severe hot flashes. The first experiment lasted for 12 weeks and the other for 24 weeks. Researchers found that Brisdelle was more effective than placebo in reducing hot flashes though it had a few side effects including headache, fatigue and nausea/vomiting.

The drug contains 7.5 mg of paroxetine, comparatively lesser than in other medications like Paxil and Pexeva, which are prescribed for treating obsessive-compulsive disorder, panic disorder and generalized anxiety disorder. The FDA states that the recommended dose for Brisdelle is once daily, preferably at bed time.

All medications prescribed for treating depression come with a boxed warning about an increased risk of suicide in children and young adults and since Brisdelle contains the same content as Paxil and Pexeva, it comes with a similar warning along with an additional caution about possible reduction in the effectiveness of tamoxifen if both medications are used together, an increased risk of bleeding and a risk of developing serotonin syndrome.
Article Source - http://www.hngn.com/articles/6570/20130629/fda-approves-non-hormonal-drug-hot-flashes-during-menopause.htm