FDA Approves New Drug for Hot Flashes
(NEW YORK) -- The Food and Drug Administration approved a new and somewhat controversial drug to treat moderate to severe hot flashes and night sweats associated with menopause on Friday.
There are several drugs that treat hot flashes, which up to 75 percent of women experience, but Brisdelle is the first one that is non-hormonal. It contains a low dose of paroxetine, which is used in higher doses in the antidepressant drug Paxil.
Many are surprised that the FDA approved the drug after an expert advisory panel voted ten to four against it, saying it risks outweighed its benefits. But the FDA says many women are now opposed to hormonal treatments since being linked to increased risk of breast cancer.
“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, director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “[Friday’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.”
According to the FDA, the most common side effects of Brisdelle are headache, fatigue, and nausea and vomiting.
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