Doctor Questions Safety Of New Pill To Boost Women’s Libido

By Richard Halstead
The Marin Independent Journal, Novato, Calif.

If you drink don’t drive and, if you’re a woman, also don’t take Addyi, the new medication approved by the U.S. Food and Drug Administration earlier this month for treating low libido in women.

That’s the message that women need to hear loud and clear from their physicians, says Dr. Jennifer Gunter, a Kaiser Permanente OB/GYN who lives in Mill Valley.

Gunter said she was astounded to discover recently that a crucial study of how Addyi affects women who have consumed alcohol was conducted using mostly men.

“I’m sure I swore,” Gunter said. “How is this possible?”

Gunter made the discovery after reading the “Risk Evaluation and Mitigation Strategy” issued by Addyi’s manufacturer, Sprout Pharmaceutical. The FDA requires companies to issue a safety strategy to doctors and pharmacists when a new drug has known or potentially serious risks associated with its use.

The stated goal of the Addyi evaluation was to mitigate the increased risk of severely low blood pressure and fainting due to an interaction with alcohol.

Mostly men
The evaluation states that the alcohol interaction study was conducted with 23 men and two women.

“So basically there is no safety data on the effects of women using alcohol and Addyi,” Gunter said. She says what is particularly worrisome is the demonstrative effects that the interaction had on this group of mostly young, healthy men. Women metabolize alcohol differently than men.

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