Low-Dose Paroxetine Won't Cause Weight Gain in Women With Hot Flashes

Low-dose paroxetine (Brisdelle) treatment does not cause weight gain or sexual dysfunction when used in women with menopausal hot flashes, according to exploratory analyses of pooled data from a pair of phase 3 trials.

“Many physicians and patients are aware of reports of sexual dysfunction and changes in body weight in patients taking selective serotonin reuptake inhibitors (SSRIs) and, specifically, paroxetine at the higher doses used for depression and other psychiatric disorders,” said study co-author Joel Lippman, MD, FACOG, executive vice president of product development and chief medical officer for Noven, which manufactures Brisdelle. “This may be an important factor when considering treatment for moderate to severe hot flashes, and these analyses, with their limitations, may help provide physicians with a better understanding of Brisdelle.”

For their analyses published in the October 2014 issue of Menopause, researchers evaluated the impact of once-daily Brisdelle 7.5 mg capsules on body weight and sexual function in postmenopausal women aged 40 years or older who experienced moderate to severe vasomotor symptoms (VMS).

After 24 weeks of treatment, the investigators found no clinically meaningful or statistically significant changes in weight or sexual function from baseline in either trial’s paroxetine group. By comparison, they observed small yet statistically significant increases in weight in the pooled placebo arm at week 4.

In terms of limitations, the authors noted that the study was not specifically designed to evaluate sexual dysfunction in VMS, and it had a relatively short duration of treatment and follow-up.

Although Brisdelle received FDA approval in June 2013 for the treatment of moderate to severe VMS associated with menopause, the low-dose SSRI has not been studied or approved for any psychiatric use. However, paroxentine 20 mg (Paxil) is indicated to treat major depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, premenstrual dysphoric disorder, and posttraumatic stress disorder.