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First Non-hormonal Drug Approved by FDA for Hot Flashes

If you’ve been suffering from hot flashes and night sweats, but were reluctant to take medications with hormones, you now have an alternative. The FDA announced that it has approved Brisdelle, the first non-hormonal drug to treat moderate to severe hot flashes. That’s great news, right? Well, sort of. It turns out the drug isn’t really new at all. Brisdelle is simply a lower dose of paroxetine, the same drug contained in the anti-depressants Paxil and Pexeva.

The New York Daily News reports that paroxetine “has been prescribed off-label by doctors for years as a treatment for menopausal symptoms.” Despite this widespread use, earlier this year, the FDA’s independent advisory committee voted not to approve Brisdelle because there was insufficient evidence to support that the benefits of the drug outweighed the risks. Nevertheless, the FDA approved Brisdelle last month.

“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, M.D. M.M.Sc., of the FDA. However the agency admitted, “The mechanism by which Brisdelle reduces hot flashes is unknown.”

SSRIs can be dangerous

Paroxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). According to the Mayo Clinic, these drugs work by affecting naturally occurring chemical messengers (neurotransmitters), which are used to communicate between brain cells. SSRIs block the reabsorption (reuptake) of the neurotransmitter serotonin in the brain. While doctors don’t understand how, the drugs seem to help alleviate symptoms.

Like all SSRIs, Paroxetine will carry a Boxed Warning of an increased risk of suicide. Additional labeled warnings include a possible reduction in the effectiveness of tamoxifen (used to treat breast cancer), an increased risk of bleeding, nausea, headache, fatigue and vomiting.

Patients who abruptly stop taking SSRIs may experience what’s known as antidepressant discontinuation syndrome. Its symptoms include insomnia, chronic nausea, flu-like symptoms and hyperarousal (a heightened state of psychological and physical tension).

SSRIs may pose risks during pregnancy

Although most women who suffer from hot flashes no longer have their period, they can also occur during perimenopause — the process of change that leads up to menopause — which may start as early as your 30’s. If you are or may become pregnant, we caution you to speak to your doctor before taking an SSRI such as Brisdelle.

SSRIs have also been linked to persistent pulmonary hypertension in newborn babies, according to articles published through the Mayo Clinic. Studies have also linked the drugs to severe birth defects, increased risk of miscarriage, and low birth weight.


First nonhormonal treatment for hot flashes, Brisdelle, approved by FDA” by Tracy Miller, New York Daily News, July 2, 2013.

“FDA approves the first non-hormonal treatment for hot flashes associated with menopause” FDA News Release, June 28, 2013.