5 Things to Understand about Addyi, the 'Female Viagra' Pill

The words “female Viagra” have been bouncing around websites and daytime talk shows for years. As soon as Viagra came on the market in 1998, people started asking, “What about women?”

Then, in 2015, flibanserin (brand name Addyi) was approved by the FDA as the first drug to tackle hypoactive sexual desire disorder, an ailment that only recently made its way into the medical industry vernacular.

So, great! We did it, right? Sexual freedom and orgasms for all!

Well, no. While Addyi is a big step for women and feminism, it may not totally be a step in the right direction.

Here are five things you should know about Addyi before you - or any other women in your life - start taking it.

Addyi Isn't Female Viagra

While a lot of people keep throwing around the terms “female Viagra” and “pink Viagra,” it’s an inaccurate comparison. Viagra dilates blood vessels, causing an erection. It gives people with penises the ability to have sex, not necessarily the desire. It doesn’t change any components of brain chemistry, and it only needs to be taken as needed.

Addyi,on the other hand, works on neurotransmitters in the brain. Originally, the drug was developed as an antidepressant. It was sold after its first failure with the FDA. Because it works on brain chemistry, it needs to build up in the system over time in order to work, which means women must take Addyi every day.

Its Efficacy Is Disputed

This is where things get really messy. The FDA rejected Addyi twice, once for concerns that there was no real evidence that Addyi worked. In the first study, women were asked to keep a daily journal of “sexually satisfying events.” What constitutes as a sexually satisfying event, or SSE, isn't as straightforward as you might think. An SSE isn’t restricted to the act of having sex, either with a partner or with yourself. It doesn't need to include an orgasm. An SSE can be both incredibly vague and vary case by case.

In the first study, both the control group (the ones taking the placebo) and the group taking Addyi reported slightly higher SSEs. The increase was marginal, though, and there was no real difference between the control group and the test group. The pharmaceutical company was able to convince the FDA to allow them to do another study. This time, instead of having women report back daily, they were asked to give a single score for their SSEs over the entire month. By changing the parameters of the study, the pharmaceutical company was able to use the peak-end effect, giving them a small advantage. Even with the changes, though, women only reported an additional 0.5-1 SSE per month compared to the placebo.

Proponents of the drug say that if you are a woman with hypoactive sexual desire disorder, even one extra SSE a month is worth it. That might be true for some women, but it is seems like a high price to pay for marginal (at best) results.

There Are Serious Side Effects

Most drugs come with an off-putting list of side effects, but the list for Addyi seems alarming even by normal drug standards. Addyi is a sedative, so it can be incredibly dangerous to mix it with other sedatives, including alcohol. Some patients who drank with Addyi experienced such a drastic drop in blood pressure that they passed out. Not exactly the best side effect if your goal is to increase sexy time.

The FDA was so worried about the interaction between Addyi and alcohol that they required the pharmaceutical company to run a test specifically looking at that interaction. The pharmaceutical company put together another study, but with only 25 participants. Even a middle school science teacher would tell you that 25 participants isn't enough for a science fair project, much less for a study of a possibly dangerous drug. But it gets worse - so much worse.

Out of those 25 participants, only two of them were women. At the advisory committee meeting, the team representing Addyi claimed that they could only find two women who drank enough to fit eligibility requirements for the study. That implausibly high bar? A woman who consumed more than five drinks a week. The pharmaceutical company claimed they couldn’t find more than two women who have a glass of wine with dinner or went out once or twice a week to have drinks with friends.

However, more recent research by the company has shown moderate alcohol consumption to be safe. Sample sizes are still small here, so take this as you will.

Addyi can also have some pretty serious interactions with other drugs, most concerning of which are some forms of birth control and some migraine medications. There can even be bad reactions with certain over-the-counter vitamins. The list of possibly dangerous interactions is so long that any doctor that prescribes Addyi, as well as any pharmacist who dispenses the drug, must go through a FDA mandated training process.

Should It Have Been Approved by the FDA?

The National Women’s Health Network, a Washington D.C. based women’s health and consumer protection agency, has spoken out against Addyi since 2010, when the FDA first looked at the drug. “Pharma always has more power than they should when it comes to FDA approval,” said Cindy Pearson, the Executive Director of the NWHN. “So we worried that flibanserin might be approved, even though it clearly did not deserve to be.”

In 2015, Addyi was once again brought in front of the FDA, even though many of the focal points of the last two rejects were still addressed. A number of doctors and scientists wrote to the FDA recommending that, once again, the drug be rejected. The NWHN also showed up, again, at the hearing and told the FDA that approving this drug would be a dangerous mistake. The concerns of the medical community were not enough, though, and the FDA finally approved Addyi. According to Pearson, this happened because the FDA gave into pressure from the pharmaceutical company and their incredibly slick and effective marketing campaign, Even the Score.

While the drug couldn’t muster much support in the medical community, it was able to find that support in the feminist community. Addyi was cheered by some (mostly their great marketing team) as the great equalizer. A pink pill that signifies a new era where women’s pleasure matters.

Addyi Might Work for You, But Other Things Might Too

Some women go their whole lives without experiencing much sexual desire. Other women have an incredibly high sex drive at certain points of their lives that later fades. At some point, every woman goes through periods of highs and lows. It could be a consequence of any number of factors including stress, relationship status, life satisfaction, hormone cycles, and maybe even what you ate earlier that day. We don’t really know all of the factors that go into sexual desire. Our sexuality is always a part of us but how big that piece is will wax and wane over time.

“I think we need to know a lot more about what is normal for women,” says Pearson. “For example, how common is it for women to lose spontaneous desire, but still experience responsive desire? How common is it for spontaneous desire to re-emerge on its own without treatment? Would education about sexual pleasure, including sex toys, help women with lack of desire? What is the success rate of "talk" therapy with trained sex therapists? Without knowing answers to all those important questions, it's doubtful that we'll make much progress.”