Addyi (flibanserin) has been approved by the U.S. Food and Drug Administration as the first drug to treat low sexual desire among premenopausal women.
The drug is for women who do not have an underlying physical or psychological cause for the disorder, the agency said in a news release.
Addyi’s label will warn that it can cause blood pressure to drop severely and may lead to loss of consciousness. These risks increase and symptoms may become worse when alcohol is consumed. So, Addyi users are warned to not to drink any alcohol, the FDA said.
Doctors who prescribe the drug and any pharmacy that dispenses it must be certified, the agency said. Pharmacies must warn users of the risks of drinking alcohol while on the medication.
People who take the once-daily drug should discontinue use after eight weeks if there’s no improvement in sexual desire, the FDA added. Addyi was evaluated in clinical studies involving some 2,400 premenopausal women. Users of Addyi reported a significant increase in sexual desire, compared to those who took a placebo.
The most common adverse reactions included dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth. The agency said it encouraged women who used the drug to report any side effects to its Adverse Event Reporting Program at www.fda.gov/MedWatch.
Addyi is marketed by Raleigh, N.C.-based Sprout Pharmaceuticals.
Visit the FDA to learn more.
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