FDA Re-examining Sex Pill for Women

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An advisory panel for the United States Food and Drug Administration said it was going to take a third look at a drug designed to treat the lack of sexual desire in women.

The little pink pill began testing in 2010 with women who had virtually no sexual desire participating in the study.  This study was led by Dr. James Simon, of George Washington University School of Medicine.  Simon also happened to be a consultant for the drug company producing the little pink pill.

"It increased the number of sexual events that the women in the trial found to be satisfying," said Dr. Simon.

Despite this evidence from the clinical trials, the FDA rejected the drug, known as Flibanserin twice in the last five years, saying the benefits of the drug simply do not outweight the side effects which include dizziness and nausea.  In a new review of the drug, new safety issues were also brought to light that include low blood pressure, fainting and accidental injury. 

Several women's health organizations have said that a low libido in women is often not a medical problem, but actually a psychological one.  Many of these organizations were also concerned about the side effects of this drug.

"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.

Even with these concerns, many women have said the drug has helped.  Barbara Gattuso originally signed up for the trial at the age of 66 back in 2010.  "Within a week it was a total transformation."  Gattuso says that she believes the drug could give women an option that haven't had before. 

Amanda Parrish had been diagnosed with Hypo Active Sexual Desire Disorder, or a low sex drive, by doctors also took part in the trial.  "It was just a light switch in my head that been turned off and once it got turned on things were fine," said Parrish.

According to Sprout Pharmaceutical, the makers of the drug, 45 percent of women who took the drug experienced increased sexual desire.  This was slightly more than the 35 percent who took the 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.

Some, however, believe the FDA should 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.

According to doctors, 90 percent of the libido is from the neck up and that's how the little pink pill works.  It alters the chemicals in the brain with the goal of increasing the desire for sex.