US Health Officials Expand Approval of Female Libido Drug to Older Women
The US Food and Drug Administration (FDA) has announced the expansion of approval for Addyi, a drug aimed at boosting female libido, to include women over 65 years old. This decision broadens the drug’s use to older women who have gone through menopause, a significant development in women’s health.
According to the FDA, Addyi was first approved in 2015 for premenopausal women experiencing emotional stress due to low sex drive. The drug, marketed by Sprout Pharmaceuticals, acts on brain chemicals that affect mood and appetite. However, its initial approval was met with controversy due to its side effects, including dizziness and nausea, and a boxed warning about the dangers of combining it with alcohol.
History of Addyi and its Impact on Women’s Health
The medical condition of hypoactive sexual desire disorder (HSDD) has been recognized since the 1990s and is thought to affect a significant portion of American women. After the success of Viagra for men in the 1990s, drugmakers began investing in research and potential therapies for sexual dysfunction in women. However, diagnosing HSDD is complicated due to the various factors that can affect libido, especially after menopause.
Doctors are required to rule out other issues, such as relationship problems, medical conditions, depression, and other mental disorders, before prescribing medication. The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem. The FDA rejected Addyi twice before its initial approval in 2015, citing modest effectiveness and worrisome side effects.
Expansion of Approval and Future Implications
The FDA’s decision to expand approval of Addyi to older women reflects a decade of work by Sprout Pharmaceuticals to change how women’s sexual health is understood and prioritized. Cindy Eckert, CEO of Sprout, stated that the approval “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.” The company announced the FDA update in a press release, highlighting the significance of this development for women’s health.
The expansion of approval for Addyi may have significant implications for women’s health, particularly for those who have gone through menopause. As the FDA continues to monitor the safety and effectiveness of the drug, it is essential for women to consult with their healthcare providers to discuss the potential benefits and risks of Addyi. For more information, visit Here
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