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First female viagra approved in the US

The first drug to treat low sexual desire in women won approval from U.S. health regulators on Tuesday, but

The U.S. Food and Drug Administration on Tuesday approved the first drug to treat low sexual desire in women but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol.

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.”

Reuters however reports that 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.”

An advisory panel had in June asked the FDA to approve the drug with strict measures in place to ensure patients are fully aware of the risks.

Unlike Viagra, which affects blood flow to the genitals, Addyi is meant to activate sexual impulses in the brain. It is similar to a class of other drugs known as selective serotonin reuptake inhibitors, or SSRI’s, that include antidepressants such as Prozac.

Women who took Addyi in a clinical study had an increase of about one sexually satisfying event per month compared with those taking a placebo. Advocates claim that increase is meaningful. Critics say the small benefit is outweighed by the drug’s risks

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