FDA Approves Low-Dose Antidepressant, Brisdelle for Hot Flashes

The U.S. Food and Drug Administration has now approved Brisdelle, a non-hormonal drug, for treating hot-flashes in women.

Until now, most of the drugs that aimed at reducing hot flashes in women either had estrogen or estrogen and progestin. The new drug Brisdelle is a lower dose of antidepressant paroxetine, or Paxil, for treating vasomotor symptoms (hot flashes).

Women reach menopause at around 45-55 years of age (or earlier if they've undergone certain medical treatments). During menopause, levels of estrogen and progesterone begin to drop. About 75 percent of women undergoing menopause have hot flashes. The condition isn't dangerous, but can lead to inconsistent sleep, discomfort and annoyance.

Brisdelle has about 7.5 mg of paroxetine. Other drugs such as Paxil and Pexeva that contain paroxetine in higher doses are used to treat major depressive disorders obsessive-compulsive disorder, panic disorder and generalized anxiety disorder, the agency said.

In menopausal women, using Brisdelle was associated with headache, fatigue, and nausea/vomiting.

"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.

In March 2013, the FDA's advisory committee on reproductive drugs had voted against the approval of the drug as it found its effectiveness, inadequate. Women who were taking placebo during the clinical trials for the drug reported a 40-48 percent reduction in symptoms of hot flashes, The Los Angeles Times reported.