WASHINGTON • The first drug to treat low sexual desire in women has won approval from US health regulators but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol.
The US Food and Drug Administration (FDA) said on Tuesday that the pink pill, made by Sprout Pharmaceuticals to be sold under the name Addyi, will be available only through certified healthcare professionals and pharmacies due to its safety issues.
Addyi, which needs to be taken daily, is designed for pre-menopausal women whose lack of sexual desire causes distress. The condition is formally known as hypoactive sexual desire disorder, or HSDD.
Addyi has been nicknamed the "female Viagra" even though it does not work like Pfizer'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) legitimises 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.
The FDA had twice rejected the 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.
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 that include antidepressants like 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.
Addyi will come with a prominent "boxed warning" about side effects, including among people with liver impairment or who take Addyi with alcohol or with medicines known as CYP3A4 inhibitors that include certain steroids.
Originally developed by Germany's Boehringer Ingelheim, it was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks. Sprout acquired the drug, conducted additional studies and resubmitted the application. In 2013, the FDA rejected it again.
The rejection sparked a lobbying campaign by Sprout, aided by some women's groups which accused the FDA of gender bias because it had approved Viagra for men - a charge the FDA vigorously rejected.
REUTERS
