Earlier this month, the U.S. Food and Drug Administration (FDA) changed the safety labeling for Addyi (flibanserin), a medication used to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Women with this type of HSDD have little or no interest in sex, even though they have had a satisfying libido in the past. This lack of interest occurs in all types of sexual situations and causes great distress. HSDD can put significant strain on women’s relationships.
First approved in August 2015, Addyi balances the levels of serotonin, dopamine, and norepinephrine in the brain.
All three chemicals are neurotransmitters, and while dopamine and norepinephrine are linked to sexual excitement, serotonin can inhibit sex drive. If levels of dopamine and norepinephrine are too low and levels of serotonin are too high, sexual interest can be altered.
The drug’s packaging originally included a boxed warning against drinking alcohol while using Addyi. At that time, there were cases of women experiencing low blood pressure (hypotension) and passing out (syncope) when mixing the two substances. Healthcare providers and pharmacists were required to counsel patients about these concerns.
Based on the results of two studies conducted since Addyi’s approval, the FDA is changing the language in the boxed warning.
In one trial, women took Addyi and drank alcohol at the same time. None of the women experienced hypotension or syncope, but the risk could not be thoroughly evaluated because of missing or delayed blood pressure measurements.
The second trial found that the risk of hypotension and syncope decreased if two hours elapsed between drinking alcohol and taking Addyi.
The FDA described the labeling changes as follows:
Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that 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 is manufactured by Sprout Pharmaceuticals.
“New Research Shows ‘Female Viagra’ Safe to Mix with Alcohol — What to Know”
(March 21, 2019)
International Society for Sexual Medicine
“What is flibanserin and how does it work?”
U.S. Food and Drug Administration
“FDA orders important safety labeling changes for Addyi”
(Press release. April 11, 2019)