FDA approves first non-hormonal treatment for hot flashes
Good news for women this week who have delayed getting care for hot flashes out of concern that most treatments contain hormones. The U.S. Food and Drug Administration (FDA), has approved the very first non-hormonal treatment for the menopause-associated flashes.
The new drug, Brisdelle is marketed by Noven Therapeutics, LLC. It is approved to treat moderate to severe hot flashes. Makers of the drug say it contains paroxetine, which is a selective serotonin reuptake inhibitor (SSRI) antidepressant that is sold under the brand names Paxil and Pexeva.
It is important to note that both Paxil and Pexeva carry a warning about an increased risk of suicide in young adults and children. Because Brisdelle contains the same active ingredient, it also has a warning about suicide risk included on its label.
Additionally, there is a warning about a possible reduction in the effectiveness of tamoxifen as well as an increased risk of bleeding when both drugs are taken together. Brisdelle is taken once daily at bedtime.
The FDA says approval of drug was based on two clinical trials that included a total of 1,175 postmenopausal women. Brisdelle was found to be more effective than a placebo at reducing hot flashes. Common side effects included headache, fatigue, nausea and vomiting.
In an online news release, the director of the FDA’s Center for Drug Evaluation and Research, Dr. Hylton Joffe, said, “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.”
Right now there are a number of FDA-approved treatments on the market for hot flashes, but all contain either estrogen or estrogen and a progestin.
According to the latest U.S. Census data, there are approximately 37.5 million women reaching or currently at menopause (ages 40 to 59). Menopause-related hot flashes can occur in up to 75 percent of these women and can last for five years or even longer.
While hot flashes are not considered to be a threat to your health, doctors say they can cause extreme discomfort, embarrassment and sleep disruption.
Experts say if you are experiencing menopausal symptoms, you should contact your doctor to develop a treatment plan than can help ease your symptoms.
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