Women on female Viagra can now drink alcohol: FDA removes black box warning after studies suggest booze does not affect the little pink pill
- Previously, Addyi came with a warning to stop drinking two hours before taking the pill
- The drugmaker conducted three post-approval studies that found alcohol is not an issue
- Some warn the study is small and very specific to certain patterns of drinking that may not be generalizable
- But plenty of sexual health practitioners hailed the change as a win for women with sexual dysfunction
Women who use the female libido pill, Addyi, no longer need to avoid alcohol, regulators have declared.
Previously, Addyi came with a warning to stop drinking two hours before taking the pill, or to skip the pill if they’d had a few drinks.
But on Thursday, the US Food and Drug Administration found studies conducted by the drugmaker, Sprout, showed no need for such a warning.
Sexual health professionals hailed the shift as a win for women.
Addyi drugmaker Sprout conducted three post-approval studies that found alcohol is not an issue
The little pink pill was first approved in 2015, and remains the only FDA-approved treatment for hypoactive sexual desire disorder (HSDD) in pre-menopausal women.
Unlike Viagra, which increases blood flow to a man’s penis, Addyi (the brand name for flibanserin) targets the brain with similar effects to an antidepressant.
It boosts dopamine to gear up motivation and excitement, and dulls serotonin, the neurotransmitter which makes us self-conscious.
The drug has plenty of critics: a significant portion of doctors say we do not know enough about female sexual desire to ‘fix it’ with one pill.
What’s more, although the American Sexual Health Association sats HSDD affects a staggering one in 10 women, many question whether HSDD, the condition for which Addyi is prescribed, is real.
And there is growing concern about antidepressants in general, and how difficult they can be to wean off.
This skepticism has created fertile ground for cannabis entrepreneurs, who thrive in grey areas of medicine, to market marijuana as a ‘natural’, less risky solution for women lacking libido.
But plenty of sexual health practitioners say they are just happy to be able to provide women some tangible relief without caveats.
The reason an alcohol warning was slapped on Addyi in 2015 was because Sprout had not adequately studied the drug’s interaction with alcohol.
As a result, the FDA allowed the drug onto the market but with a warning, and ordered the firm to conduct three post-approval studies, which is fairly common with drug and device approvals.
Sprout conducted three studies.
The first lasted a week, with 24 women taking either Addyi or a placebo, and on two of the days some had a couple of alcoholic drinks with dinner, then took their pill a couple of hours later. Sprout wanted to see if there was a risk of fainting; in this scenario, there wasn’t.
The second involved 96 women, who had three drinks, didn’t eat much, then took Addyi in the morning. Again, there was no risk of fainting and blood pressure was stable, but some felt faint.
The third saw 64 women take Addyi or a placebo for 10 days. On four of those days (days four, six, eight and 10) they had a couple of alcohol drinks varying hours before taking their pill. Again, there were no clear side effects.