Add thelocalreport.in As A Trusted Source
US health officials have expanded the approval of a much-discussed drug aimed at increasing female libido, saying the once-a-day pill can now be taken by women over 65.
The announcement Monday from the Food and Drug Administration expands the drug’s use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive.
Addyi, marketed by Sprout Pharmaceuticals, was initially expected to be a blockbuster drug that would fill an important niche in women’s health. But the drug came with unpleasant side effects, including dizziness and nausea, and it carries safety warnings about the dangers of combining it with alcohol. box warning, fdaThe most serious type, warns that drinking alcohol while taking the pill can cause dangerously low blood pressure and fainting.
sales Addyi, which acts on brain chemicals that affect mood and appetite, has 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 brain chemicals.
Sprout CEO Cindy Eckert said in a statement that the approval “reflects a decade of consistent work with the FDA to fundamentally change the way women’s sexual health is understood and prioritized.” Company based in Raleigh, North Carolinaannounced the FDA’s decision in a press release on Monday.
According to surveys, the medical condition of worryingly 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. After the blockbuster success of viagra In the 1990s, drug manufacturers began investing money into research and treatment of sexual dysfunction in women.
But diagnosing the condition is complicated because of how many factors can affect libido, especially after menopause, when falling hormone levels trigger many biological changes and medical symptoms. Doctors must rule out many other issues, including relationship problems, medical conditions, depression, and other mental disorders before prescribing the medication.
The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.
The FDA had rejected Addyi twice before its 2015 approval, citing the drug’s modest effectiveness and side effects. The approval decision 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.
,
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.