'Female Viagra' Has Limited Benefits, Negative Effects

March 1, 2016
Amy Jacob

The drug flibanserin, approved last year by the FDA to enhance sexual desire in women entering menopause, apparently produces less-than-satisfying results.

The drug flibanserin, approved last year by the FDA to enhance sexual desire in women entering menopause, apparently produces less-than-satisfying results.

Dubbed the ‘female Viagra,’ flibanserin (Addyi/Sprout Pharmaceuticals) was considered to be a potentially groundbreaking treatment for hypoactive sexual desire disorder (HSDD) or sexual interest/arousal disorder, which affects 10-40% of women.

Working differently than sildenafil (Viagra/Pfizer), flibanserin increases levels of dopamine and norepinephrine — safety issues that raised concerns about the medicalization of women’s sexuality.

Following the historic FDA approval, Loes Jaspers, MD, Erasmus University Medical Center, Rotterdam, the Netherlands, and colleagues conducted a meta-analysis of the records of clinical trials for 5,914 women to investigate the medication’s efficacy and safety.

Findings showed that “premenopausal and postmenopausal women who took the approved dose (100mg) of flibanserin experienced 0.5% more satisfying sexual encounters a month and scored 0.3 points higher on a five-point sexual desire scale.”

What does this mean?

The overarching opinion from the women surveyed suggested that the drug led to “either minimal or no improvement.”

Furthermore, the drug drastically increases dizziness, sleepiness, nausea, and fatigue among female users.

Additionally, reports indicated combining flibanserin with alcohol and other common drugs could result in dangerous hypotension and syncope — two grave problems that could warrant a black box warning.

While this is a study that already garnered much interest from healthcare and public officials, experts agree further studies, including women from diverse populations and those with other conditions, are necessary.

Steven Woloshin, MD, and Lisa Schwartz, MD, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, remarked, “The flibanserin saga is unsatisfying. The FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial, and unnecessary, uncertainty about its dangers. Women with distressing sexual desire problems need good treatments. We all need a drug approval process that delivers good decisions based on adequate evidence.”