FDA To Take Another Look At The 'Little Pink Pill' For Women
BOSTON (CBS) - The "Little Pink Pill" to treat low libido in women. The FDA has already rejected it twice, but Thursday there will be another push to get it on the market. Dr. Mallika Marshall reported on this drug a few months ago and says there are more concerns raised about the pill's safety.
A lot of folks have been wondering what is taking so long to get a Viagra-like drug out there for women. As you can imagine when it comes to sexual dysfunction, women can be more complicated than men. For women the causes can be physical, emotional, and psychological. So it's difficult to find just one pill that can help most women.
Flibanserin, by altering hormones in the brain, was found in clinical trials to help more women than a placebo, but the FDA rejected it twice, saying that it didn't help enough women to justify the side effects of nausea, dizziness, or sleepiness. There are now concerns that it could lead to low blood pressure, fainting, and accidental injury.
"This drug increases satisfying sexual events by less than one per month and one out of five women is going to have an adverse effect," says Dr. Adriane Fugh-Berman of PharmedOut at Georgetown University Medical Center.
The FDA advisory panel will take another look at the drug and make a another recommendation to the FDA. The FDA does not have to follow the panel's advice, but it usually does.