FDA Expands Approval of Addyi to Boost Libido in Postmenopausal Women Up to 65

By

FDA Expands Approval of Addyi to Boost Libido in Postmenopausal
cottonbro studio/Pexels

US health officials have expanded the approval of Addyi, a daily pill designed to boost sexual desire in women, allowing postmenopausal patients up to age 65 to use the drug.

The Food and Drug Administration announced the decision Monday, marking a major change for a medication that has long been debated in women's health care.

According to AP News, Addyi was first approved in 2015 for premenopausal women who experience emotional distress linked to very low sex drive.

With the new update, doctors can now prescribe the drug to older women who have gone through menopause, a group that often faces hormonal and physical changes that affect sexual desire.

The pill, made by Sprout Pharmaceuticals, works on brain chemicals tied to mood and appetite rather than hormones.

It was once expected to become a major treatment option, similar to how Viagra reshaped care for men.

Instead, its impact has been limited due to side effects such as dizziness and nausea, along with strict safety rules.

Addyi carries a boxed warning about alcohol use. Drinking while taking the pill can lead to dangerously low blood pressure and fainting.

The label advises patients who have had several drinks to wait hours before taking a dose or skip it altogether. These warnings have made some patients and doctors cautious.

FDA Move Expands Addyi Access After Years

In a statement, Sprout CEO Cindy Eckert said the expanded approval "reflects a decade of persistent work with the FDA to fundamentally change how women's sexual health is understood and prioritized."

The company said the decision gives more women access to a treatment option that had been unavailable to them.

Low sexual desire linked to distress is often diagnosed as hypoactive sexual desire disorder, a condition recognized since the 1990s, US News reported.

Surveys suggest it affects a large number of women in the United States. After Viagra's success in the 1990s, drugmakers invested heavily in finding treatments for women, but progress has been slower and more complex.

Doctors say diagnosing low libido is not simple. Especially after menopause, desire can be influenced by many factors, including health problems, medications, mental health, stress, and relationship issues.

Medical guidelines require providers to rule out these causes before prescribing Addyi.

The condition itself remains controversial. Some experts argue that low sex drive should not always be treated as a medical problem, while others say the lack of treatment options has left many women without support.

Before its original approval, the FDA rejected Addyi twice, raising concerns about its modest benefits and safety risks.

Tags
FDA

© 2025 VCPOST.com All rights reserved. Do not reproduce without permission.

Join the Conversation