The female libido pill, named Addyi, has been available to pre-menopausal women with hypoactive sexual desire disorder (HSDD) since October. Yet, a recent review of the “little pink pill” has some questioning its benefits.
As reported by Fox News, a team of Dutch researchers analyzed eight different studies on Addyi, or flibanserin, and found only minimal meaningful changes. Looking at data obtained from 6,000 women who were taking 100 milligrams daily of the female Viagra, the researchers discovered roughly 0.5 additional “satisfying sexual events” per month.
Not only did the drug do little to enhance female libido, it caused one-third of the women to experience side effects like dizziness, sleepiness, and nausea, according to the research team. About 60 percent of the women saw an increase in fatigue, were four times as likely to have dizziness, and twice as likely to experience queasiness.
Flibanserin is marketed by Valeant under the brand name Addyi and manufactured by Sprout Pharmaceuticals. Last August, the FDA approved the female libido pills with a strong warning on the label that indicated the risk of low blood pressure and fainting when taken with alcohol, other drugs, or have liver problems.
“The FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial — and unnecessary — uncertainty about its dangers,” wrote Dr. Steven Woloshin and Dr. Lisa Schwartz at the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice.
Woloshine and Schwartz contend that Sprout as well as other interested parties put pressure on the FDA to get the drug approved. They say the science used in their clinical trials was “weak,” and lacked sufficient evidence to provide a good decision.
Lead researcher Dr. Loes Jaspers, of Erasmus University Medical Center in Rotterdam, the Netherlands, says the new study results should send a message to the FDA that Addyi’s approval needs to be reconsidered.
“It could be that at the time of approval they thought the level of evidence was higher than what was found in our study,” she wrote in an email. “Also, they may have taken into consideration other aspects in their decision making, that were not covered in this review and meta-analysis.”
Dr. Tage Ramakrishna, chief medical officer for Valeant, stated the research actually confirms the findings of the trials used for the FDA approval. However, he noted that reviewing the existing data does not carry the same weight as the clinical trials.
Despite criticism of the female libido pills, some doctors and patients say the drug has helped. Currently, there is no other FDA-approved alternative for women with low sex drive.
Dr. Lauren Streicher with the Center for Sexual Medicine at Northwestern Memorial Hospital believes the study results, published in JAMA Internal Medicine, are just averages. She says that Addyi isn’t a solution for everyone, but many of her patients have seen positive differences in sexual relations.
Some have questioned the researchers’ procedure since three of the eight studies analyzed were not published. If a study is published, a peer review is done to determine the reliability of the methodology.
One unpublished study reviewed by the Dutch researchers used a dosage of Addyi that was half the recommended amount as approved by the FDA. However, Jasper says that doesn’t matter since after removing the results of that particular study, they still found the benefits of the female Viagra to be minimal.
“We included all published and unpublished studies to capture a complete overview of the benefits and risks of flibanserin, without bias,” Jaspers wrote in an email to CNN.
Addyi enhances female libido by influencing brain receptors to increase sexual excitement in women. According to the researchers, low or no sex drive affects between 10 and 40 percent of women.
[Photo by AP Photo/Allen G. Breed]