US FDA approves 'female Viagra' with strong warning

The first drug to treat low sexual desire in women won approval from U.S. health regulators on Aug. 18, but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol. 

The U.S. Food and Drug Administration said the pink pill, to be sold under the brand name Addyi and made by privately held Sprout Pharmaceuticals, will only be available through certified and specially trained health care professionals and pharmacies due to its safety issues. 

Addyi, whose chemical name is flibanserin, is designed for premenopausal women whose lack of sexual desire causes distress. The condition is formally known as hypoactive sexual desire disorder, or HSDD. The drug needs to be taken daily. 

Addyi has been nicknamed the "female Viagra" even though it does not work like Pfizer Inc's blockbuster Viagra pill for men that in 1998 became the first approved drug for erectile dysfunction. 

"This is the biggest breakthrough in women's sexual health since the advent of 'the Pill'" for contraception, The National Consumers League said in a statement. "It validates (and) legitimizes female sexuality as an important component of health." 

But Public Citizen, a consumer watchdog group that testified against the drug earlier this year, predicted that Addyi will be pulled from the market within a few years because of "serious dangers to women, with little benefit" to them. "Unfortunately, we haven't heard the last of this drug." 

The FDA had twice rejected the Raleigh, North Carolina-based firm's drug. But the latest decision comes after an advisory panel concluded in June it should be approved with strict measures in place to ensure patients are fully aware of the risks.