FDA Scientists Cite Ineffectiveness, Side Effects In Review Of Female Libido Drug

An FDA background document released Wednesday found that a pill aimed at treating female sexual dysfunction failed to make a significant difference in two studies, although some women reported slightly more sexually satisfying experiences, the AP/Detroit Free Press reports. On Friday, an FDA panel of experts will consider the drug -- flibanserin -- for premenopausal women who report a lack of sexual desire. The agency is not required to follow the panel's advice.

According to the FDA document, two studies conducted by the drug's maker, Boehringer Ingelheim, failed to show a significant increase in female participants' libido, as recorded by the women in a daily journal. Although some women reported a boost in satisfying sexual experiences, the FDA document said agency scientists "wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not" (Perrone, AP/Detroit Free Press, 6/16).

FDA also noted that certain side effects -- fatigue, sedation and drowsiness -- were "commonly reported." The review said that "it is not clear if labeling alone will be sufficient to alert women to the numerous drug interactions that exist" with the drug, adding that nearly 15% of women who participated in the study stopped taking the drug before the study ended because of possible side effects (Richwine, Reuters, 6/16).

Debate on Sexual Desire Surrounds Approval Efforts

The effort to obtain FDA approval of flibanserin has triggered a debate on female sexual dysfunction, with some critics saying that Boehringer "is trying to turn a low libido into a medical pathology," the New York Times reports. In seeking approval for the drug, the company cites a legitimate psychiatric condition called hypoactive sexual desire disorder, or HSDD.

Although there is "no dispute" that some women experience lower levels of sexual desire, sexual dysfunction issues are "much harder" to diagnose and treat in women than in men, the Times reports. Critics argue that the company's marketing campaign for the pill overstates the prevalence of female sexual dysfunction and falsely leads women to think they need medical treatment, the Times reports (Wilson, New York Times, 6/16).

NBC News Examines Flibanserin Debate

NBC's "Nightly News" on Wednesday also reported on the FDA review and efforts to treat HSDD (Snyderman, "Nightly News," NBC, 6/17).


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