"Female Viagra" is ineffective and harmful, new research suggests. After taking a closer look at Valeant Pharmaceuticals International Inc.'s pill Addyi, approved in 2015 by the U.S. Food and Drug Administration for enhancing female sex drive, health researchers found that the so-called Female Viagra was just marginally more effective than sugar pills.
What's more, Addyi, also called Flibanserin, has also been linked to several worrying side effects. After analyzing eight clinical trials involving more than 5,900 women, Dutch researchers at Erasmus University Medical Center in Rotterdam found that one in three women reported negative side effects like nausea, fatigue, dizziness and insomnia.
With all the negative side effects associated with Addyi, health experts are debating whether the pill, approved last year to treat hypoactive sexual desire disorder in premenopausal women, is even worth the risk.
"When articles that reflect opinion rather than science are published in scientific journals, they harm those meant to be aided by science and medicine resulting, in this case, in a great disservice to the millions of pre-menopausal women suffering from HSDD," the International Society for the Study of Women's Sexual Health (ISSWSH) said in a statement.
Hypoactive sexual desire disorder, which affects both men and women, is defined by the Diagnostic and Statistical Manual of Mental Disorders as "persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity. The judgment of deficiency or absence is made by the clinician, taking into account factors that affect sexual functioning, such as age and the context of the person's life."
The latest study, published in The Journal of the American Medical Association's Internal Medicine, revealed that women taking Addyi experienced just "one-half additional satisfying sexual events" every month compared to women taking placebo pills. Researchers noted that Addyi's marginal benefits were also paired with significant "risk of dizziness, somnolence, nausea, and fatigue," compared to women taking placebo pills.
"Before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause," researchers concluded in the study.
Addyi was approved in August 2015 after an FDA advisory committee voted 18-6 to recommend approval. The approval had been based on results from three phase three clinical trials that showed a significant improvement in female sexual dysfunction.
