The Food and Drug Administration has finally given a green signal to world's first drug to boost the sex drive of a woman, the Washington Post reports.
The controversial drug, flibanserin, which will now be marketed as Addyi was rejected by the FDA two times over the agency's concerns about the side effects of the drug, before the approval granted on Tuesday.
The drug now comes with a labeled warning of the risk of low blood pressure and fainting, induced if the drug is taken along with alcohol. The FDA has also asked the drug manufacturer, Sprout Pharmaceuticals, to conduct 3 studies in women to better understand the serious known risks of this drug and alcohol. The agency also recommends that women stop using the drug if they experience no change in their libido after 8 weeks.
Addyi is intended to treat a condition called Hypoactive Sexual Desire Disorder, or chronic low libido in pre-menopausal women that cannot be explained by any medical or psychological factors.
According to Washington Post, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement, "Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies.
"Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."
