A key advisory committee to the Food and Drug Administration voted Thursday in favor of recommending approval to the drug being billed as the first-ever "female Viagra". The drug, flibanserin, has already been rejected twice by the FDA citing concerns over possible side effects that outweigh the benefits to otherwise healthy women struggling with low sexual desire.
Committee members voted after an afternoon spent listening to impassioned testimony from women suffering with Hypoactive Sexual Desire Disorder, who described the distressing condition as being as though a switch had suddenly turned off their interest in having sex, and medical practitioners who expressed their wishes to help these women when there is no current treatment available.
Potential adverse effects of flibanserin that the FDA found troubling include fainting, nausea, dizziness, sleepiness, and low-blood pressure. But this list does not differ greatly from the adverse effects found in clinical trials of sildenafil, or Viagra, which counts headache, indigestion, and impaired vision (with some men even complaining of cyanopsia, or blue-tinted vision) among commonly reported side effects, and prolonged erections, severe low blood pressure, and heart attacks among it's rare but serious potential adverse effects.
Committee members also worried about the results of one cancer study in mice that showed an increased risk of developing breast tumors. However, these results were obtained when the mice were given four times the therapeutic dose and Sprout Pharmaceuticals, the developers of the drug, explained that the results of this singular animal study have not been found to predict cancer in humans.
The committee vote was described as "difficult" for many of the members, but ultimately the decision was made with an 18-6 vote to recommend the drug for approval with conditions, especially regarding the use of the drug with alcohol, certain other medications, or by pregnant women.
Sally Greenberg of the National Consumers League said, “We know this is a problem with their brain chemistry. Just like depression. And, just like depression, their brain chemistry can be adjusted. We can treat it. And we should treat it.”
Photo: AP
