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Women seeking treatment for Hypoactive (low) Sexual Desire Disorder (HSDD) may no longer have to choose between enjoying a cocktail and improving sexual desire.
Addyi, the first medication approved to treat female sexual dysfunction, specifically Hypoactive (low) Sexual Desire Disorder (HSDD), has continued to receive national attention since its release in 2015. The FDA approved Addyi in 2015, but recently issued a safety label change order to its manufacturers. The FDA specifically requested the safety label be updated to reflect risks while drinking alcohol when taking the medication.
Women suffering from HSDD may not want to choose between enjoying a glass of wine and treating their HSDD symptoms. The change order for the safety label of this medication has caused some confusion for stakeholders across the country.
All About Addyi
Addyi, commonly referred to as the “pink pill,” is a unique medication that works to treat generalized HSDD in pre-menopausal women. Addyi is not technically the “female Viagra,” because it acts on serotonergic neurons in the brain to improve desire, whereas Viagra works by improving blood flow. HSDD is the most common form of female sexual dysfunction, making this development a significant milestone for improving women’s sexual health.
Concerns over interactions between alcohol consumption with Addyi have fueled controversy in recent months.
Controversy Over Mixing Alcohol & Addyi
The FDA issued a safety label change order on April 11, outlining language changes to clarify alcohol consumption remaining a concern when using Addyi. Sprout Pharmaceuticals began the FDA’s appeal process the same day, also requesting the restrictive elements of the Risk Evaluation and Mitigation Strategy (REMS), known as the ETASU, be revised.
In addition, Sprout invested more than $10 million to research interactions between Addyi and alcohol, ultimately finding that the risk of fainting or experiencing low blood pressure while drinking and taking the drug is not as severe as was initially believed.
The appeal process concluded on August 18 and the FDA’s Office of New Drugs released a final decision letter stating that Sprout may submit a request to modify the REMS, as well as a revised label that removes the contraindication for use of alcohol with Addyi. The Director of the Office of New Drugs commented that new evidence demonstrated that the risk of consuming alcohol with Addyi was narrowed and the restrictive ETASU was no longer necessary for those prescribing and dispensing Addyi.
Sprout complied with the FDA’s request guidelines on August 29 and published a press release on September 4, stating the FDA had approved the revision of their warning regarding alcohol use with the medication and the requirements surrounding the REMS process for prescribing and dispensing Addyi. However, the FDA requested Sprout retract the September 4 press release, claiming it could be misleading to stakeholders.
Sprout released a timeline of the FDA appeal process and press release on their site in order to clear up inconsistencies in wake of the recent controversy.
The Verdict
Despite the promising decision letter released on August 18, the FDA has not yet approved Sprout Pharmaceuticals’ final updated safety label for Addyi. Sprout states they will continue to work with the FDA throughout the implementation process for the new label. For now, it seems the controversy has been settled.
Regardless of the recent controversy, the release of Addyi is monumental for women struggling with HSDD. For those using the medication, it is best not to drink alcohol, or to discontinue alcohol consumption at least two hours prior to taking their dose.
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Shelby is a public health professional with research and field experience in sexual and reproductive health. She holds a Master of Public Health (MPH) and is a Certified Health Education Specialist (CHES).