FDA Raises Concerns About “Women’s Viagra”
WASHINGTON, June 3 (UPI) — The Food and Drug Administration will consider approval of the female libido drug flibanserin for the third time, after rejecting it previously on concerns that it caused fainting, dizziness and nausea.
A public relations campaign has also increased attention on the FDA’s consideration of flibanserin because of the seemingly minor potential side effects as compared with those associated with male libido drugs.
Flibanserin is under consideration for use by premenopausal women whose lack of sexual desire causes distress, called hypoactive sexual desire disorder. Unlike erectile dysfunction drugs which target smooth muscle relaxation and increase blood flow, potential female libido drugs like flibanserin target brain chemistry.
In previous trials of the drug, researchers reported that women taking flibanserin had 4.4 “satisfying sexual experiences” per month, compared 3.7 for those taking a placebo and 2.7 before the study. While the data is statistically significant, the agency didn’t consider it enough of a benefit. Additionally, the concerns about fainting, dizziness and nausea have specifically been pointed to as areas of concern in both previous rejections.
Some women’s groups have accused the FDA of a double-standard because there are 6 drugs on the market for erectile dysfunction, many of which have much worse potential side effects than those associated with flibanserin.
“It looks to me like there are more hurdles being put in front of this drug than there have been on drugs addressing male dysfunction,” Terry O’Neill, president of the National Organization for Women, told The Washington Post. “Obviously, everyone only wants drugs to get on the market if they are proven safe and effective. But we don’t want attitudes to get in the way of a good drug.”
The FDA report on filbanserin is available on the agency’s website.
