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Last week, a new drug called Addyi, manufactured by Sprout Pharmaceuticals, was approved by the Food and Drug Administration (FDA). The drug is intended for use by pre-menopausal women diagnosed with hypoactive sexual desire disorder (HSDD). It works by boosting dopamine and norepinephrine levels in the brain. While this may seem like good news for women who are experiencing distress or interpersonal difficulties due to low levels of sexual desire, this one-of-a-kind drug comes with significant risks and a black-box safety warning.

Before its recent approval, Addyi had been rejected twice by the FDA due to safety concerns. Sprout then conducted three new drug interaction safety trials, leading to the drug’s approval. The black box warning describes the risk of low blood pressure and fainting spells. These side effects can be amplified by alcohol use. Doctors are even warned by the FDA to “assess the likelihood of the patient reliably abstaining from alcohol” before describing the medication.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said FDA drug approval chief Janet Woodcock in an official statement. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

We expect to see the launch of Addyi in October. At an estimated cost of up to $75 per month, health plan sponsors will have to decide whether to cover the drug.

It stands to reason that if health plans cover other so-called lifestyle drugs, such as erectile dysfunction medications, they will likely cover this drug, as well, rather than face potential perceptions of gender bias or discrimination. A foundation called Even the Score exists solely for the purpose of, in its words, “leveling the playing field when it comes to the treatment of women’s sexual dysfunction.” With this kind of attention on the new drug, and any others that may follow, health plans are likely to carefully consider their decisions about coverage.