Addyi Side Effects May Outweigh Benefits For Women: Study

New research suggests that the side effects of Addyi, a recently approved drug described as the “female Viagra”, may outweigh the minimal benefits provided in increasing female sexual desire. 

In a study published earlier this week in the online edition of the medical journal JAMA Internal Medicine, researchers from the Netherlands indicate that Addyi actually does very little to improve a woman’s sex life, while increasing the risks of dizziness, sleep problems, nausea and fatigue.

Addyi (flibanserin) was approved by the FDA in August 2015, for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The agency had previously rejected approval of the Sprout Pharmaceuticals medication in both 2010 and 2013, due to questions over whether the benefits justify the risks.

In this latest study, researchers looked through medical databases and trial registries for studies that included a total of 5,914 women, looking for the number of satisfying sexual events (SSEs), as well as reports of adverse events and side effects. They found five published studies and three unpublished studies that compared women given 100 mg of Addyi with those given a placebo.

According to the findings, women taking Addyi only experienced an average of one-half of an additional satisfying sexual event per month. However, they faced a four-fold increase in the risk of dizziness, and somnolence, a 235% increased risk of nausea, and a 64% increased risk of fatigue.

“The most common reported AEs (adverse events) were of mild and moderate intensity, and serious AEs were equally low in flibanserin and placebo users. This reflects positively on flibanserin’s safety, but the conclusion that flibanserin is safe is premature,” the researchers concluded. “The continued safety (and efficacy) of flibanserin with long-term use remains to be established.”

Addyi Safety Questions

In an accompanying editorial, Drs. Steven Woloshin and Lisa M. Schwartz, of the Center for medicine and the Media at Dartmouth Institute for Health Policy and Clinical Practice in New Hampshire, questioned the wisdom of the FDA’s approval of Addyi, due to the potential safety risks.

According to the FDA, the drug can cause severely low blood pressure, known as hypotension, as well as loss of consciousness, referred to as syncope, particularly when taken with alcohol or certain medications, such as Prilosec, Depakote and even grapefruit juice, which are all known as strong CYP3A4 inhibitors. This led the FDA to place a black box warning on the new drug, which was the strongest warning the agency could require to ensure women were informed about the risk of Addyi side effects.

“The flibanserin saga is unsatisfying,” the doctors wrote in the editorial. “The FDA approved a marginally effective drug for a non-life threatening condition in the face of substantial — and unnecessary — uncertainty about its dangers. “Women with distressing sexual desire problems need good treatments. We all need a drug approval process that delivers good decisions based on adequate evidence.”

Shortly after the drug was approved, the consumer watchdog group Public Citizen predicted that the drug would have a short shelf life, suggesting that an Addyi recall will be issued once enough women had been seriously harmed by the “irreversible, or life-threatening injuries” linked to the medication.