FDA Orders Safety Label Change for Addyi Regarding Alcohol Consumption

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When Sprout Pharmaceuticals Addyi was approved in 2015, it came with a “black box warning” label due to serious side effects, particularly severely low blood pressure, which were exacerbated by the consumption of alcohol. On Thursday, that alcohol-related warning was removed from the label.

The U.S. Food and Drug Administration (FDA) issued a safety-labeling change for Addyi, a treatment for female sex drive. The changes to the label will now reflect that while alcohol consumed while taking Addyi can still cause some complications, the concerns were not as high as previously thought and women who use the medication will no longer have to avoid consumption of alcohol.

The FDA said in its announcement that Sprout had requested a complete removal of the warning regarding alcohol. However, the agency said following a review of the data, that “removing this important safety information was not acceptable for the protection of public health.” Some of the data from the post-marketing studies showed that “many more women had missing or delayed blood pressure measurements when they took Addyi and alcohol together compared to when they received alcohol alone or Addyi alone,” the FDA said.

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Addyi was approved to address a low sex drive, called hypoactive sexual desire disorder (HSDD) in premenopausal women. At the time of approval, Addyi was compared with male counterparts, such as Viagra or Cialis. However, Addyi addresses desire, not performance.

Following approval, as well as a topsy-turvy history with the drug being passed between multiple companies before winding back up in the hands of its developers, the FDA required additional studies relating to Addyi and alcohol. Based on the results of post-marketing studies, the FDA has determined that changes must be made to Addyi's labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely, Sprout said. The warning label will be updated to indicate that women should not drink alcohol two hours prior to taking Addyi at bedtime, as recommended. Women should not consume alcohol at least until the morning after taking Addyi at bedtime, the FDA said.

Julie Beitz, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research's Office of New Drugs, said the agency recognizes women want access to treatments for female sexual dysfunction and wants to ensure the safety of the drugs. Beitz said the FDA wants to ensure that the most accurate safety information is included in the labeling of prescription medications.

"We work diligently with companies to make labeling updates but occasionally are unable to reach agreement. In those rare cases, such as with Addyi today, we have important authorities to compel companies to make safety labeling changes that are critical for the safe use of an approved product. We are taking this action because it is our responsibility to help protect the safety of those who take prescription medicines, which includes helping to ensure that patients are provided access to the most up-to-date information about the drugs they take," Beitz added.

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