Brisdelle: Non-Hormal Treatment for Hot Flashes Approved by FDA

First Posted: Jun 29, 2013 03:46 PM EDT
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The U.S. Food and Drug Administration recently approved the first non-hormonal drug that can be used to treat hot-flashes in woman.

The drug, known as Brisdelle, is a lower dose of the antidepressant paroxetine, or Paxil, for treating vasomotor symptoms. 

According to the drug company's website, Brisdelle has about 7.5 mg of paroxetine. Other drugs that contain paroxetine, such as Paxil and Pexeva, are commonly used to treat major depressive disorders.

Though some side effects listed with the drug include headache, fatigue and nausea, health officials are hopeful about the future use of the drug in menopausal woman.

Women reaching the state of menopause at around 45 to 55 years of age show a reduction in the levels of estrogen and progesterone produced throughout their body. About 75 percent of women undergoing menopause have hot flashes, and though this is not a serious condition, it can lead to lasting discomfort that can interrupt sleep and daily activities. 

"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. 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," said Hylton V. Joffe, M.D., director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, according to a statement.

Despite remarks that the FDA advisory committee initially shot the drug down in March 2013, according to The Los Angeles Times, as they were uncertain about the alleged benefits of the product, reports show that health officials are moving forward with its use.

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