On August 18th, 2015, the FDA approved Flibanserin (Addyi) to help premenopausal women who were experiencing low sexual desire that resulted in personal distress or difficulties. Taken in tablet form, this non-hormonal pill acts as a “multifunctional serotonin against antagonist” (MSAA) to provide treatment for those facing hypoactive sexual desire disorders. Whilst this may sound like a good idea on paper, the safety and testing behind this “female viagra'' is both dangerous and problematic.
Flibanserin, also called Addyi, went through the normal approval protocol, giving the illusion that it was safe for female consumption. It comes as a 100mg dose that should be taken daily right before bedtime. There are however multiple dangerous side effects that Flibanserin may cause which this 2018 paper goes into detail about. Administration during waking hours increased the chances of hypotension, syncope (passing out), accidental injury, and depression. Flibanserin “may also cause (CNS) depression with somnolence and sedation. Fatigue, insomnia, and dry mouth can also occur.” Those taking Flibanserin should not drive or engage in any activities that require full alertness until it has been at least 6 hours after taking flibanserin. At this point, I’m beginning to wonder how the heck this was even passed as a safe drug. But it gets a lot worse from here…
Biased Trials of Flibanserin
When investigating the effects of Flibanserin when consuming alcohol (spoiler alert: it reacts really badly), Sprout Pharmaceuticals (creator of Flibanserin) conducted a rather controversial study. Now I’m no scientist, I barely even passed biology, but common sense says that this study should be carried out on mostly female subjects, especially due to the way that women metabolize alcohol in a completely different way to men. Yet Sprout Pharmaceuticals decided to conduct this “dedicated alcohol interaction study with Addyi in 23 men and 2 premenopausal women.” Whilst their decision to do this is rather confusing, their conclusions and findings are even more so. The summary given states that:
Four of 23 subjects (17%) co-administered Addyi 100 mg and the equivalent of two glasses of wine had events of hypotension or syncope.
Six of the 24 subjects (25%) co-administered Addyi 100 mg and the equivalent of four glasses of wine experienced orthostatic hypotension when standing from a sitting position
The ambiguity in this means that neither conclusion separates the results for gender – we don’t know whether both women fainted after the wine, or if neither did.
Whilst this study was not one of the original clinical trials, its findings are still just as significant. The manufacturer came to the conclusion that: “Patients must not take Addyi unless they can abstain from alcohol use for the full duration of treatment.” Barbara Speed, editor, and writer at the New Statesman, reached out to Sprout Pharmaceuticals to ask about the unhelpful gender divide, and the spokesperson responded explaining that “more men than women agreed to enroll in this kind of study” which frankly sounds like a cop-out and clearly goes against their duty and responsibility to provide a safe drug for patient care.
Women in Pharmaceutical Clinical Trials
Female underrepresentation in clinical trials is not something new. A 2020 study found a gender gap in drug doses for 86 medications that had been approved by the Food and Drug Administration (FDA). Female hormonal fluctuations are the primary reason for our exclusion from the trials, with the idea being that our hormones make the study harder to conduct in a way it can complicate the results. Because of this studies and, in turn, dosage recommendations have been based on male bodies. This has dangerous consequences. In 2013, the FDA decided to cut the dosage from the sleeping aid Ambien in half for women as the drug left them still drowsy in the morning and hence at a greater risk for accidents – that was 21 years after the drug had been approved for sale. To make matters worse, it turns out the creators and researchers actually knew about the problem in 1992 when it received data that revealed the amount of Ambien in a woman’s blood was 45 percent more than the men—yet the FDA failed to act.
Whilst there has been some increase in women in clinical trials, there are still issues. Nancy Pire-Smerkanich, assistant professor in the School of Pharmacy at USC states that:
“Women are actually well represented in the later stage trials, those known as Phase 3 studies…However, the dosing regimens used in later stage studies are based on the pharmacokinetic data collected in the early trials, where women continue to be underrepresented.”
Why Some Take Flibanserin
Healthy sexual functioning is shown to be important to all individuals, so it’s no wonder many turns to Viagra, either in the male or female form. The 2018 article mentioned previously questions the reasoning behind Flibanserin and Viagra in reference to HSDD. Hypoactive Sexual Desire Disorder (HSDD) was removed from the fifth edition of the Diagnostic and Statistical Manual of Mental Disorder (DSM-V), causing the authors of this journal article and others to question whether HSDD exists at all. They further question “considering that it was no more included as a separate entity in DSM-V, is drug treatment the right way forward?” With all the dangerous side effects of both male and female viagra, I too question why these drugs exist and what alternatives there are to them.
Understanding desire and arousal is a complex task and something that requires more research and deliberate inclusion of female voices. We need to move away from pills that do more harm than good and find alternatives that aren’t “doing yoga” or “drinking red wine” as this Bustle article suggests. Drinking red wine is not going to “fix” feelings about sexual desire (or a lack of it), but open and honest conversations – whether that is with a close friend, partner, or therapist – will help.
By Stephanie McCartney