FDA Taking Another Look At Sex Pill For Women
Follow CBSMIAMI.COM: Facebook | Twitter
MIAMI (CBSMiami) - A drug to treat a lack of sexual desire in women is getting a third look by the Food and Drug Administration advisory panel.
Barbara Gattuso first saw a drop in her sex drive 30 years ago. Happily married, she said it was devastating.
"I had tremendous feelings of love and respect for my husband but I just had no sexual desire," said Gattuso.
The 66 year old signed up for a clinical trial in 2010, testing a little pink pill from Sprout Pharmaceutical for women with low libido called Flibanserin.
Dr. James Simon, of George Washington University School of Medicine, was an investigator on the clinical trials and is a consultant to the drug company.
"It increased the number of sexual events that the women in the trial found to be satisfying," said Dr. Simon.
The FDA has rejected Flibanserin twice in the past five years, saying the benefits do not outweigh side effects which include dizziness and nausea. A new review released Tuesday also highlighted safety issues including low blood pressure, fainting, and accidental injury.
CLICK HERE to watch CBS4's report
Several women's health organizations say low libido in women is often not a medical problem, but a psychological one and they're concerned about the drugs side effects.
"This drug increases satisfying sexual events by less than one per month and one out five women is going to have an adverse effect," said Dr. Adriane Fugh-Berman from Georgetown University Medical Center.
Despite the concerns, Gattuso said the drug has help her.
"Within a week it was a total transformation," she said.
Gattuso added that she believes the drug could give women an opiton they've never had. Doctors diagnosed Amanda Parrish with Hypo Active Sexual Desire Disorder (HSDD), a low sex drive.
"It got to where I'd be one of those women who would try to maybe be asleep before he got to bed," said Parrish.
Parrish also took part in a clinical trial for Flibanserin.
"It was just a light switch in my head that been turned off and once it got turned on things were fine," said Parrish.
Sprout Pharmaceutical said 45 percent of women who took the drug experienced increased desire. That's slightly more than the 35 percent who took a placebo.
Dr. Bat Shava Marcus, who treats women with sexual dysfunction, said disagrees with the FDA's first two passes on the drug and believesthe benefits do outweigh the risks.
"Women are smart consumers. They're not going to use it if the side effects are miserable," said Doctor Marcus.
Still, some said the FDA is right to be cautious.
"I don't think it's completely unreasonable that we have a high bar for safety when we are looking at drugs for low libido for men or women," said Dr. Jan Shifren with Massachusetts General Hospital.
Doctors said 90 percent of the libido is from the neck up and that's how the little pink pill works. It increases the sex drive by altering chemicals in the brain.
