A recent series of studies, funded by Sprout Pharmaceuticals, show that Addyi, also known as the “female viagra,” is potentially safe with moderate alcohol use. However, some experts aren’t convinced — and neither is the FDA.
In 2015, the Food and Drug Administration (FDA) approved Addyi (flibanserin), a prescription medicine heralded as a long overdue “female Viagra.” It also slapped a black box warning on the package to call attention to side effects of the drug considered serious or life-threatening.
Chief among them: women who took the drug while drinking alcohol ran the risk of losing consciousness.
Recently, Addyi’s manufacturer, Sprout Pharmaceuticals, announced results of some new research in hopes of getting that concerning warning removed.
“The additional insights provided by these three new studies are invaluable for a more comprehensive understanding of Addyi for safe use,” said Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, in a press release. “This additional data contextualizes and further clarifies the relationship between Addyi and alcohol.”
Yet some experts aren’t convinced it proves the drug is safe to take with alcohol — and neither is the
Based on the results of the new studies, Sprout must change their labeling to clarify the risks of drinking alcohol close in time to taking Addyi.
Addyi is the first and only FDA-approved treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. The condition is just what it sounds like: basement-level libido to the point of personal distress. The American Sexual Health Association reports that 1 in 10 women have HSDD.
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The FDA rejected Addyi twice, citing both small effects and major safety concerns like low blood pressure that can lead to a sudden and prolonged loss of consciousness. These risks increase when Addyi is taken with certain other drugs or alcohol.
Finally allowing that HSDD is an “unmet medical need,” the FDA approved Addyi on its third review, with a few caveats. Aside from the black box warning, only certified doctors and pharmacies who’ve completed special training can prescribe or dispense the drug. Patients not only have to be counseled to abstain from all booze, but sign an agreement form promising to do so. Their doctor has to sign, too.
At that time, the FDA also noted that Addyi’s interaction with alcohol hadn’t been adequately studied. One safety study, for instance, enrolled 23 men and only two women, even though this is a drug for women. Three post-approval trials from Sprout were required to dig a little deeper.
Of the three new studies funded by Sprout, the smallest one was designed to simulate a “real world scenario.” For three days, 24 healthy premenopausal women took either Addyi or a placebo. Then on the fourth and sixth day, they had either two alcoholic or nonalcoholic drinks with dinner, plus either Addyi or a placebo two and a half hours later at bedtime. No one fainted.
A second study with 96 women was arranged as a “worst-case scenario,” in which Addyi was taken along with two or three drinks and consumed within 10 minutes in the morning following an overnight fast and light snack. No episodes of fainting or dangerously low blood pressure requiring medical care were observed, although participants did feel drowsier.
The last study tested the impact of drinking alcohol when taking Addyi. Sixty-four healthy women were given either a single daily dose of Addyi or a placebo for three days. On days 4, 6, 8, and 10, they then had two alcoholic drinks 2, 4, or 6 hours prior to taking Addyi or a sugar pill. Like the other studies, there were no reported episodes of fainting or low blood pressure.
“The largest study is really a ‘worst-case scenario’ where the drug was delivered during the day to almost 100 women. That [study] didn’t show any issue, how many more would you need?” said Dr. James A. Simon, CCD, NCMP, IF, FACOG, clinical professor of OB/GYN at George Washington University School of Medicine, medical director at IntimMedicine Specialists in Washington, D.C., and the primary researcher on the study.
“If you look at the actual clinical trials, the six-month trials,” Simon continued, “the incidence of hypotension and syncope are about equal, slightly more, in the Addyi group than the placebo, but not statistically different. About 60 percent of women were social drinkers in the trials, and even in the Addyi group, the incidence of hypotension and syncope were under 1 percent.”
However, experts who weren’t associated with the research were less enthusiastic about the results.
“These studies don’t seem very persuasive to me,” said Diana Zuckerman, PhD, president of the National Center for Health Research. “They are a good start, but they’re not very big and certainly aren’t very long. The cumulative effect of taking this drug could be quite different.”
For instance, what happens if a woman taking Addyi drinks two days a week for a month? Or every day for a month?
All the studies tell us, Zuckerman said, is what may happen if a woman taking Addyi drinks exactly like the other women in the studies. And even that’s not a guarantee since “not everyone will metabolize the drug or the alcohol the same way,” Zuckerman said.
Dr. G. Thomas Ruiz, OB/GYN lead at MemorialCare Orange Coast Medical Center in Fountain Valley, California, agreed.
“The way something is studied is not what goes on in real life,” Ruiz said, adding Sprout will need much larger studies to convince the FDA to alter Addyi’s packaging. “It’s very unusual for the FDA to remove black box warnings. Pharmaceutical companies have to go through extraordinary means to get that removed.”
Plus, noted Ruiz, Addyi still interacts with many other medicines that are commonly prescribed to women and which can cause the same adverse side effects as alcohol. These include oral medicines used to treat yeast infections, antibiotics, high blood pressure medications, and antihistamines like over-the-counter Benadryl. Taking combined oral contraceptives at the same time as Addyi may make you more likely to experience an adverse reaction.
After reviewing the study results, the FDA decided that changes should be made to Addyi’s labeling, but that black box warning isn’t going anywhere. Instead, it and other sections of Addyi’s labeling will be updated to reflect that women don’t need to abstain from alcohol completely, but should stop imbibing at least two hours before taking Addyi at bedtime or skip their dose of Addyi that evening.
And if Addyi is taken at bedtime, no booze should be consumed at least until the morning after.
If your libido could use a boost and you’re interested in trying Addyi, keep in mind:
It’s not for everyone. “The guidelines to use it are very rigid and women need to be aware of that,” Ruiz said. For instance, Addyi can’t be prescribed to menopausal women or anyone with a history of depression.
Watch your booze intake. Take these new FDA guidelines seriously. And keep in mind: Despite what these studies show, the FDA warnings pertaining to alcohol and Addyi remain unchanged. So, you’ll need to play it safe and abstain from drinking altogether. “Alcohol can cloud your judgment. This drug could cloud it even more,” warns Zuckerman.
Be vigilant about your meds. Don’t assume your doctor or pharmacist will remember that you’re taking Addyi. Remind them before you’re prescribed, or begin taking, any additional meds. That goes for over-the-counter drugs and herbal supplements too.
It’s not a magic pill. According to the prescribing information on the company’s website, researchers found that the drug only added one additional “satisfying sexual encounter” per month.
“Low libido is something that’s hard to deal with. Usually, in my experience, there’s an underlying issue causing it,” said Ruiz. That could be a problem in your relationship, inhibitions about sex, or poor body image, all of which may be helped by counseling.