It’s official: the Food and Drug Administration (FDA) supports every woman's right to pursue her best orgasm possible. In a landmark decision, they’ve approved Addyi (flibanserin), a.k.a. “Viagra for women.” It was created as an answer to hypoactive sexual disorder (HSDD), which plagues women with low libidos that mess with them both physically and emotionally. “HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance,” says the FDA release. Although “Viagra for women” is a bit of a misnomer since Viagra increases blood flow, not sexual desire, some hail the drug as a pharmaceutical godsend.
Lady boners rejoice! #femaleviagra #flibanserin
— Rocio (@cheezits4life) August 18, 2015
Yes it has happened!! Thank you FDA for all women! A milestone in women's health! #addyi #flibanserin
— Risa Kagan MD FACOG (@risakmd) August 18, 2015
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Flibanserin has a complicated history, to say the least. It’s been up for approval twice before, once in 2010 and again in 2013. The first time, the FDA cited nine reasons the drug didn’t pass muster, including incomplete testing and minimal changes in women’s sexual desire. The second time, those nine concerns were reduced to six, mainly revolving around potential side effects like intense fatigue and a negative alcohol interaction. Then, in June of this year, an FDA committee showed its support for women’s orgasms. In an 18-6 vote, they rallied behind flibanserin, but the vote wasn’t binding—today easily could have gone in the opposite direction.
It’s worth noting that every single one of the 18 members who voted in flibanserin’s favor said it needed to be investigated more carefully to cut back on any risk. To help ensure it’s as safe as possible, the FDA is using a risk evaluation and mitigation strategy (REMS) that requires health care professionals and pharmacies be certified before doling out the drug. The FDA is also being up front about the drug’s worrisome potential interaction with alcohol. “Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope)," says the release. "These risks are increased and more severe when patients drink alcohol.”
Because of that, the FDA is requiring any health care professionals who prescribe the drug to evaluate whether a woman will actually stop drinking while on it because those side effects are no joke. The drug will also have a warning label on the box to further send the message that it’s not something to be taken lightly.
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While some people are clearly throwing their full weight behind the drug, others are taking the FDA to task for approving what they see as an unsafe treatment option with minimal benefits at best and scary side effects at worst. Even the FDA admits it doesn’t know the exact process by which Addyi improves sexual desire. “Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known,” says the release.
Whether #flibanserin even works is very subjective, unlike #viagra. Viagra's outcome is objective, can be measured (what a job tho)
— DyNama (@DyNama) August 18, 2015
Is it #feminist to want a lower standard of safety for women's health? Absolutely not. I do not support the approval of #flibanserin #sayno
— Dayan Flynn-Walsh (@dayanfw) August 18, 2015
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If anyone’s particularly over the moon about this news, it’s people who thought flibanserin was getting rejected because of sexism. An especially controversial part of the previous flibanserin debate was whether any gender bias was involved, given that men have various drugs to help them have better sex. Even though those drugs are more about making sure their penises work physically rather than tackling the more complex task of increasing desire, some still see this as leveling the playing field.
"We are on track to make the kind of progress in gender equity that usually comes once in a generation" #flibanserin https://t.co/OYaEp0xCnP
— Dr. Serena McKenzie (@SexMedDoc) August 18, 2015
BREAKING NEWS: @US_FDA has approved the 1st-ever medical treatment for #HSDD! #ThankYouFDA!!
— Even The Score (@Eventhescore) August 18, 2015
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Although Addyi seems to have its drawbacks, the conversation surrounding the drug’s approval has brought more attention to women’s sexual satisfaction. Whichever side of the debate you land on, that’s undoubtedly a very good thing.
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