False or Misleading Claims: More Problems with Addyi

The so-called “pink Viagra” drug Addyi (flibanserin) is in the news again. This time, Sprout Pharmaceuticals, the drug’s manufacturer, is being called out by the FDA for making “false or misleading claims about the risks associated with Addyi.”

OBOS has previously written about how the health risks of the drug outweigh its benefits. The FDA approved Addyi in 2015, after Sprout Pharmaceuticals, the drug’s manufacturer, engaged in an aggressive marketing campaign designed to convince people that it was only fair that if men had an erectile dysfunction drug, women should have a drug to call their own. (The campaign was less successful with the general public: sales of the drug have been considerably below expectations.)

This past year, Sprout has been at it again, this time with a radio advertising blitz telling listeners that Addyi is “an FDA-approved pill for women frustrated by their low libido.” Not so, says the FDA, in their official warning letter to Sprout.

More accurately, the FDA says, Addyi is approved for women “who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD [Hypoactive Sexual Desire Disorder] have low sexual desire that is troubling to them. Their low sexual desire is not due to:

• a medical or mental health problem
• problems in the relationship
• medicine or other drug use”

In other words, before taking a drug that can have serious side effects, it’s important to rule out other causes for low desire, including relationship problems, medical issues, and medication side effects. In addition, many women lack education and knowledge about women’s sexuality and what they need to experience sexual pleasure and orgasm. For these women, exploring their bodies and reading “Our Bodies, Ourselves” may be more helpful than Addyi!

The FDA also reprimanded Sprout for failing to “provide material information about the consequences that may result from the use of the drug” and creating “a misleading impression about the drug’s safety.” This includes neglecting to inform users that taking the drug after drinking alcohol or taking certain prescriptions increases the risk of low blood pressure and fainting. “This is particularly concerning from a public health perspective due to the serious risks associated with the drug,” the FDA wrote.

The FDA instructed Sprout to either pull the ads or pull the drug. It remains to be seen what will be the next chapter in the story of Addyi, one that’s captured the attention of feminist health advocates for failing to deliver in so many ways, despite its grand promises to help women. The Journal of the American Medical Association summarized eight studies on the drug, which included nearly 6000 total participants total, and concluded: “Treatment with flibanserin [Addyi], on average, resulted in one-half additional SSE [sexually satisfying event] per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue.”

To be clear: That’s one additional sexually satisfying event every two months on average! If that’s the goal, there are much easier, side-effect free ways to get there and get off. But you’re not going to learn that from Sprout’s radio ads.

Marshall Miller and Dorian Solot are sex educators and the authors of “I Love Female Orgasm: An Extraordinary Orgasm Guide.”