U.S. FDA approves controversial 'female Viagra' drug

By Jill Replogle

WASHINGTON — The U.S. Food and Drug Administration on Tuesday evening approved the world’s first drug designed to stir a woman’s waning desire for sex, a condition that affects an estimated 1 in 10 U.S. women.

The approval of the controversial drug, flibanserin, which the FDA twice rejected before and now will be marketed as Addyi, comes with a series of conditions reflecting the agency’s concerns about serious side effects. These include a boxed warning that highlights the risks of low blood pressure and fainting in patients who drink alcohol while taking the drug, as well as a requirement that doctors complete a training course before being allowed to prescribe it.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Supporters of the drug hailed the decision as an end to what they called “gender bias” at the FDA, giving women more choice and control over their sexual lives. Critics said the approval of … continue reading

Via:: Tico Times