Non-Hormonal Drug for Hot Flashes Approved by the FDA

Brisdelle promises to treat moderate to severe hot flashes

By on July 1st, 2013 19:51 GMT

A non-hormonal drug that promises to treat moderate to severe hot flashes brought about by menopause has recently been approved by the Food and Drug Administration (FDA) in the United States.

The drug, named Brisdelle, is the first of its kind to have even been given the green light in this country.

“The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause.

“Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA,” the FDA writes in a press release.

The organization explains that the drug is intended for women who are experiencing menopause-induced hot flashes, but who cannot relieve their symptoms with the help of hormonal treatments.

As Hyltn V. Joffe, MD, puts it, “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. This new approval provides them with a new therapeutic option to help ease their discomfort.”

Clinical trials have shown that women taking Brisdelle can experience side effects such as headaches, tiredness and nausea.

In some cases, the drug can trigger suicidal thoughts.

The Examiner reports that this is because it contains chemical compounds that are also used to manufacture several antidepressants.

The company manufacturing Brisdelle warns that the drug should not be taken together with tamoxifen, a drug used to treat breast cancer. Apparently, when combined, the two medications can prove fatal.

“Because Brisdelle contains the same active ingredient as Paxil and Pexeva, a Boxed Warning about suicidality is included in the Brisdelle label.

“Additional labeled warnings include a possible reduction in the effectiveness of tamoxifen if both medications are used together, an increased risk of bleeding, and a risk of developing serotonin syndrome (signs and symptoms can include confusion, rapid heart rate, and high blood pressure),” the FDA explains.

People experiencing side effects from taking Brisdelle are encouraged to stop treatment and contact their doctor as soon as possible.

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