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FDA approves a drug to treat hot flashes

The US Food and Drug Administration recently approved a new treatment for hot flashes — a low-dose version of the antidepressant paroxetine (Paxil) — in a surprise move. The agency’s panel of physician experts had voted this past March to reject the treatment because the drug didn’t offer enough symptom relief to warrant exposing patients to the risk of rare side effects such as increased suicidal thoughts, bleeding, and high blood pressure.

Unlike its independent panel, the agency saw a need for at least one non-hormonal drug to reduce a common menopausal symptom, and the new drug, called Brisdelle, is the first. “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,” Dr. Hylton Joffe, a director in the FDA’s Center for Drug Evaluation and Research, said in a statement.

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Gynecologists have been prescribing antidepressants for years off-label to help alleviate night sweats and hot flashes in women plagued by sleepless nights. “The most effective treatment we have is estrogen, but in my experience, antidepressants can help a little bit,” said Dr. Isaac Schiff, chair of gynecology at Massachusetts General Hospital.

Paroxetine is typically prescribed in doses ranging from 20 to 50 milligrams per day to treat clinical depression, but the new drug contains just 7.5 milligrams, to be taken once a day at bedtime.

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