The U.S. Food and Drug Administration on Tuesday gave its approval to Addyi, a pink pill that is being called "the female Viagra," though the drug carries far more risk than the famous male erectile dysfunction drug.
For starters, the FDA will mandate doctors warn users of the dangers of consuming alcohol while taking the drug.
Prescribers of Addyi must also be certified with the Risk Evaluation and Mitigation Strategy program by enrolling and completing training, according to the FDA.
According to reports, the drug, which is taken regularly for months when prescribed, will cost women between $30 and $75 per month with insurance.
[Also: CMS spent $103 billion on Medicare Part D in 2013]
Providers must assess the likelihood of a patient reliably abstaining from alcohol before prescribing as there is an increased risk of severe hypotension and loss of consciousness when Addyi is mixed with alcohol, according to the FDA.
Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk. Additionally, pharmacies must be certified and trained to carry the drug.
Pharmacies can only give Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must warn customers not to drink alcohol during treatment.
"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified healthcare professionals and certified pharmacies," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.
"Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."
Addyi can cause severely low blood pressure and loss of consciousness, too.
Addyi is the first FDA-approved drug to improve sexual desire in premenopausal women.
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It treats hypoactive sexual desire disorder, characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric conditions, problems within the relationship, or the effects of a medication or other drug substance.
HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.
"Today's approval provides women distressed by their low sexual desire with an approved treatment option," Woodcock said.
Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.
Twitter: @SusanMorseHFN