FDA OKs libido-boosting pill for women who have gone through menopause
WASHINGTON– US health authorities have broadened approval of a highly controversial drug aimed at boosting the female libido, saying the once-a-day pill can now be taken by women over 65.
Monday’s announcement by the Food and Drug Administration expands the drug’s use to older postmenopausal women. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low libido.
Addyi, marketed by Sprout Pharmaceuticals, was initially expected to become a blockbuster drug, filling an important niche in women’s health. But the drug comes with unpleasant side effects, including dizziness and nausea, and it carries a safety warning about the dangers of combining it with alcohol. The boxed warning, the FDA’s most serious type, warns that drinking while taking the pill can cause dangerously low blood pressure and fainting.
Sales of Addyi, which works on chemicals in the brain that affect mood and appetite, have been limited. In 2019, the FDA approved a second drug for low female libido, an on-demand injection that works on a different set of neurological chemicals.
Sprout CEO Cindy Eckert said in a statement that the approval “reflects a decade of persistent work with the FDA to fundamentally change the way women’s sexual health is understood and prioritized.” The company, based in Raleigh, North Carolina, announced the FDA update in a press release Monday.
The medical condition linked to extremely low sexual appetite, called hypoactive sexual desire disorder, has been recognized since the 1990s and is believed to affect a significant portion of American women, according to surveys. After the breakout success of Viagra for men in the 1990s, drugmakers began investing money in research and potential therapies for sexual dysfunction in women.
But diagnosing the condition is complicated because of the number of factors that can affect libido, particularly after menopause, when declining hormone levels trigger a number of biological changes and medical symptoms. Doctors are supposed to rule out a number of other problems, including relationship problems, health problems, depression and other mental disorders, before prescribing medications.
The diagnosis is not universally accepted, and some psychologists say low libido should not be considered a medical problem.
The FDA rejected Addyi twice before its approval in 2015, citing the drug’s modest effectiveness and concerning side effects. The approval came after a lobbying campaign by the company and its supporters, Even the Score, which framed the lack of options for female libido as a women’s rights issue.
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