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FDA Issues Safety Labeling Changes for Addyi

FDA Issues Safety Labeling Changes for AddyiDo you or your partner take the drug Addyi (flibanserin) to treat hypoactive sexual desire disorder (HSDD)?  If so, you’ll want to take note of these safety labeling changes from the U.S. Food and Drug Administration (FDA).

Specifically, the FDA has revised its warning on the interaction or Addyi and alcohol.

Previously, women were cautioned against drinking any alcoholic beverages while taking Addyi, as doing so might increase the risk of fainting and low blood pressure.

However, after evaluating recent research, the FDA has determined that some alcohol use might be okay.

While the information is still included in the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of the packaging label, the new language reflects the following, as stated by the FDA:

  • Women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening.
  • Women should not consume alcohol at least until the morning after taking Addyi at bedtime

Addyi works by balancing levels of three brain neurotransmitters: serotonin, dopamine, and norepinephrine. When these chemicals are out of balance, women can become less interested in sex.

The FDA approved the drug in August 2015 for premenopausal women with acquired, generalized HSDD. This means that women had a healthy sex drive at one time, but it has plummeted for reasons that can’t be easily explained. They lose interest in all sexual situations and feel distress because of it.

Women who have concerns about Addyi and its side effects should talk to their doctor or pharmacist.

Resources

Healthline.com

Booth, Stephanie

“New Research Shows ‘Female Viagra’ Safe to Mix with Alcohol — What to Know”

(March 21, 2019)

https://www.healthline.com/health-news/new-study-show-female-viagra-drug-claim-medication-is-safe-to-take-with-alcohol-company-seeks-changes-to-fda-labeling

International Society for Sexual Medicine

“What is flibanserin and how does it work?”

https://www.issm.info/sexual-health-qa/what-is-flibanserin-and-how-does-it-work/

SexHealthMatters

“Addyi: Information for Healthcare Providers”

https://www.sexhealthmatters.org/hsdd/addyi-information-for-healthcare-providers

U.S. Food and Drug Administration

“FDA orders important safety labeling changes for Addyi”

(Press release. April 11, 2019)

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635847.htm