The FDA has approved paroxetine (Brisdelle, Noven Pharmaceuticals), a selective seratonin reuptake inhibitor (SSRI), to treat moderate to severe hot flashes in women with menopause.
“Today’s approval provides women with the first FDA-approved, nonhormonal therapeutic option to help ease the hot flashes that are so common in menopause,” Hylton Joffe, MD, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, said in a press release.
As many as three quarters of post menopausal women experience moderate- to severe- vasomotor symptoms, sometimes lasting five years or longer, the FDA noted, and as many as two-thirds of the 24 million affected by the condition choose not to treat their symptoms instead of opting for hormonal therapies.
“The FDA approval of paroxetine addresses the unmet need for a clinically proven nonhormonal treatment option for hot flashes and night sweats,” David Portman, MD, director of the Columbus Center for Women’s Health Research in Ohio, said in a statement.
The FDA approval is based results from two randomized, double-blind, controlled studies examining paroxetine’s effectiveness against moderate to severe hot flashes in 1,175 postmenopausal women.
Participants had a minimum of seven to eight hot flashes per day or 50 to 60 per week. Treatment with paroxetine or placebo lasted for 12 weeks in one study and 24 weeks in the other. Both studies showed paroxetine reduced the frequency and severity of hot flashes and night sweats compared with placebo.
Headaches, fatigue and nausea/vomiting were the three most common side effects, although fatigue was shown to decrease as treatment progressed over time.
The paroxetine dose approved for use against hot flashes is a much lower dose (7.5 mg) than the dose used to treat conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder and generalized anxiety disorder.
Still, the medication will contain a boxed warning regarding increased risk of suicide, as this side effect is included in the label for the drug when it is used in higher doses for the other conditions.
Other warning that will appear on the label include a warning that paroxetine may reduce the efficacy of tamoxifen if both medications are used together, along with warnings about increased risk for bleeding or developing seratonin syndrome.
by Walker Harrison, an undergraduate student at Columbia University and editorial intern with Clinical Advisor.