'Female Libido' Pill May Not Be Worth It: Report
Addyi carries host of serious side effects without delivering much more sexual satisfaction, review suggests
By Dennis Thompson
MONDAY, Feb. 29, 2016 (HealthDay News) -- The much-touted "female libido" pill seems to cause a host of serious side effects while failing to spark much additional passion in a woman's life, a new review suggests.
Addyi (flibanserin) quadruples the risk of dizziness and sleepiness, more than doubles the chances of nausea, and increases the risk of fatigue by more than half, according to the analysis.
For all that trouble, a woman taking Addyi can expect to gain one-half of one additional satisfying sexual event per month, on average, according to the report. It was published online Feb. 29 in the journal JAMA Internal Medicine.
"We found women had, on average, 2.5 satisfying sexual events per month before entering the study, and flibanserin added one-half additional satisfying sexual events per month," said senior study author Ellen Laan, a professor of sexology and psychosomatic gynecology at the University of Amsterdam, in the Netherlands.
The side effects are troubling, said Dr. Mamta Mamik, an assistant professor of obstetrics, gynecology and reproductive science at Mount Sinai's Icahn School of Medicine in New York City.
"The article is pretty comprehensive in addressing the issues. They raise valid concerns," Mamik said. "I think we have to be careful when a drug is marketed before its safety profile is approved and proper trials have been conducted."
The U.S. Food and Drug Administration approved Addyi last year after a contentious review process, making it the nation's first drug designed to help women with low libido.
Only 227 prescriptions for the drug were filled in its first few weeks on the market, Bloomberg reported.
In the new review, Laan and her colleagues reviewed eight clinical trials conducted with Addyi, including five published and three unpublished studies involving almost 6,000 women.
The combined evidence showed that Addyi provides marginal benefit for women who are suffering hypoactive sexual desire disorder, a condition involving a persistent or recurrent lack of interest in sex.
For example, women taking the drug scored just 0.3 points higher on a 5-point sexual desire scale and experienced a minimal increase in satisfying sexual events each month, the review authors found.