U.S. health officials have expanded the approval of a controversial medication aimed at enhancing female libido. The U.S. Food and Drug Administration (FDA) announced on March 25, 2024, that the daily pill, known as Addyi, can now be prescribed to women over the age of 65 who have undergone menopause. This decision broadens the drug’s application, which was initially approved in 2015 for premenopausal women experiencing emotional distress due to low sexual desire.
The approval of Addyi, produced by Sprout Pharmaceuticals, comes after ongoing discussions about women’s sexual health, a topic historically overshadowed by treatments for male sexual dysfunction. The pill is designed to influence brain chemicals that regulate mood and appetite, aiming to alleviate symptoms associated with hypoactive sexual desire disorder (HSDD).
While Addyi was initially expected to be a significant advancement in women’s health, sales have remained limited due to its side effects, which include dizziness and nausea. The FDA has issued a boxed warning—the most serious type—indicating that combining Addyi with alcohol can lead to dangerously low blood pressure and fainting.
In a statement, Sprout CEO Cindy Eckert expressed that the recent approval reflects a decade of collaboration with the FDA to enhance the understanding and prioritization of women’s sexual health.
Complexities in Diagnosing Low Libido
The condition of low sexual appetite has been recognized since the 1990s and is believed to affect a substantial portion of women in the United States. Following the success of Viagra for men, pharmaceutical companies began investing in research for female sexual dysfunction. However, diagnosing HSDD is complicated due to various factors influencing libido, particularly after menopause when hormone levels decline, leading to numerous biological changes and potential health issues.
Before prescribing Addyi, healthcare providers must first eliminate other potential causes of low libido, such as relationship difficulties, medical conditions, and mental health disorders. The lack of universal acceptance regarding the diagnosis of HSDD has led some psychologists to argue against categorizing low sexual desire as a medical issue.
The FDA previously rejected Addyi twice before granting approval in 2015. The decision followed a lobbying campaign by Sprout Pharmaceuticals and advocacy group Even the Score, which framed the limited treatment options for female libido as a matter of women’s rights.
As the conversation around women’s sexual health continues to evolve, the FDA’s recent announcement may represent a new chapter for those affected by low libido, offering hope and potential relief for older women navigating this sensitive issue.
