Washington, D.C. -- Tomorrow, the first FDA-approved drug to treat hypoactive sexual desire disorder (HSDD) in premenopausal women will be available by prescription. The National Women’s Health Network (“the Network”) remains deeply concerned over the unanswered questions regarding Addyi’s interaction with alcohol and the drug’s ability to cause serious, and even life-threatening, complications.
In clinical trials, women who took Addyi were more likely to experience sudden prolonged unconsciousness and dangerous low blood pressure (clinical hypotension). As a central nervous system depressant, alcohol may intensify these already serious effects when used in combination with Addyi, as well as other side effects such as dizziness, sleepiness and fatigue. The FDA expressed concern over these adverse events and requested the drug sponsor conduct an alcohol safety study to further assess the risks of using alcohol and Addyi at the same time. When the sponsor reneged on its responsibility to adequately test the interactions between Addyi and alcohol, the FDA approved the drug anyway, leaving women without the crucial information they need to make an informed decision.
Instead, the FDA is warning women not to drink alcohol while they take Addyi, in spite of the fact that public health officials know these warnings are not effective over the long-term. “Instructing women to stop drinking indefinitely because Sprout refused to complete a required study is outrageous”, said Cindy Pearson, Executive Director of the Network. “Sprout sold Addyi for $1 billion less than 48 hours after it received FDA approval. They had the resources to do the study correctly, but apparently chose not to. Now women will pay the price.”
The sponsor claims it was “only able” to recruit two women who were moderate drinkers to participate in their 25 person alcohol safety study. “It is inconceivable that Sprout would design a study to test the effects of alcohol on women and conduct it primarily in men,” said Pearson.
Without a rigorously designed and implemented clinical trial on women, it is impossible to fully understand the potential consequences of drinking alcohol while taking Addyi to women. “Women absorb and metabolize alcohol differently than men. Addyi was not evaluated nor will it be indicated for use in men. An alcohol-flibanserin interaction study primarily tested on men is clinically irrelevant for the purposes of evaluating its safety in women,” continued Pearson.
The Network recognizes that many women experience sexual problems for which they would like an effective, and reasonably safe, solution. Approving drugs without rigorously evaluating them beforehand is not the solution.
The National Women’s Health Network is supported by our members and by choice, we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.
Christina Cherel, MPH, is a women’s health advocate and former NWHN Policy & Advocacy Manager. Currently, she advocates globally for reproductive health research as Program Officer for the Bill & Melinda Gates Institute and as Communications Chair for the International Conference on Family Planning.