![]() ![]() ![]() However, experts who weren’t associated with the research were less enthusiastic about the results. 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.” “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. 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. That didn’t show any issue, how many more would you need?” said Dr. “The largest study is really a ‘worst-case scenario’ where the drug was delivered during the day to almost 100 women. Like the other studies, there were no reported episodes of fainting or low blood pressure. 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. Sixty-four healthy women were given either a single daily dose of Addyi or a placebo for three days. The last study tested the impact of drinking alcohol when taking Addyi. No episodes of fainting or dangerously low blood pressure requiring medical care were observed, although participants did feel drowsier. No one fainted.Ī 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. 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. 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. Three post-approval trials from Sprout were required to dig a little deeper. One safety study, for instance, enrolled 23 men and only two women, even though this is a drug for women. Their doctor has to sign, too.Īt that time, the FDA also noted that Addyi’s interaction with alcohol hadn’t been adequately studied. Patients not only have to be counseled to abstain from all booze, but sign an agreement form promising to do so. Aside from the black box warning, only certified doctors and pharmacies who’ve completed special training can prescribe or dispense the drug. These risks increase when Addyi is taken with certain other drugs or alcohol.įinally allowing that HSDD is an “unmet medical need,” the FDA approved Addyi on its third review, with a few caveats. 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. It lowers serotonin, which can impede sexual desire, while helping to fire up other neurotransmitters, like norepinephrine, which are believed to boost interest in sex. The American Sexual Health Association reports that 1 in 10 women have HSDD.īy tweaking brain chemistry, Addyi purports to help HSDD. The condition is just what it sounds like: basement-level libido to the point of personal distress. Yet some experts aren’t convinced it proves the drug is safe to take with alcohol - and neither is the Food and Drug Administration (FDA).īased 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.Īddyi is the first and only FDA-approved treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. “This additional data contextualizes and further clarifies the relationship between Addyi and alcohol.” ![]() “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. Recently, Addyi’s manufacturer, Sprout Pharmaceuticals, announced results of some new research in hopes of getting that concerning warning removed. 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.Ĭhief among them: women who took the drug while drinking alcohol ran the risk of losing consciousness. Share on Pinterest According to current FDA rules, women using Addyi not only have to be counseled to abstain from all booze, but sign an agreement form promising to do so.
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