A labeling change order was issued to Sprout Pharmaceuticals last week by the Food and Drug Administration concerning its drug Addyi (flibanserin).
Addyi is for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. The FDA is requiring changes based on a review of postmarketing studies. The changes require a revision of important safety information.
“The FDA helps ensure that the most current safety information about the use of prescription drugs is accurately reflected in product labeling, giving health care professionals and patients confidence that they are able to make the most informed treatment decisions,” 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. “We recognize that women want access to treatments for female sexual dysfunction, and we are committed to helping ensure approved therapies are safe and effective when taken as indicated and to supporting the development of new therapeutic options for female sexual dysfunction.”
The changes are needed to clarify the concern about consuming alcohol near the time of taking Addyi but the person taking the medication does not need to abstain completely from alcohol. The warnings and precautions on the medication are being updated to state that the person taking Addyi should abstain two hours before taking the medication.
“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,” said Beitz. “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.”