A new study claims that Valeant Pharmaceuticals International Inc.'s pill 'Addyi', which was designed to boost women's sex drive, has minimal effects in enhancing female libido. Moreover, taking it may cause a host of serious side effects.
Bloomberg reported that a Dutch study, published online in the journal JAMA Internal Medicine, found out that women taking Addyi gained only one additional satisfying sexual event every other month. The pill, known chemically as flibanserin, also intensifies the risks of dizziness, sleepiness, nausea and fatigue.
The researchers from Erasmus University Medical Center in Rotterdam drew their conclusions by analyzing the consolidated results from eight clinical trials involving 5,914 women. "The findings of this review suggest that the benefits of flibanserin treatment are marginal, particularly when taking into account the concurrent occurrence of adverse events," the researchers stated.
In response to the researchers' claims, Dr. Tage Ramakrishna, Valeant's chief medical officer and president of research and development and quality, told the Daily Mail that all Addy's pivotal trials showed a statistically significant increase in the number of sexually satisfying events for premenopausal women who took the pill. He added that the recent findings carry less weight compared to the Valeant's data that has been affirmed by an FDA advisory panel.
According to ABC News, Addyi, which is sometimes called 'female Viagra', is the first drug approved by the FDA to treat premenopausal women with hypoactive sexual desire disorder (HSDD), or lack of sexual desires or fantasies. Before its approval, FDA had rejected it twice due to some concerns about its effectiveness and side effects.
"It is crucial that women suffering from HSDD are able to speak to their physicians about the full range of options - including medical treatment - to manage this serious and well-established condition," Ramakrishn added. "Analyses such as the one published in JAMA Internal Medicine, by omitting context and downplaying the importance of increased sexually satisfying events to those with HSDD, makes that conversation more difficult."
