Approved by the FDA almost three years ago, the medication Addyi—often mislabeled as 'female Viagra'—is now reaching pharmacy shelves. Although certain obstacles to obtaining it have been removed, the debates around the drug remain heated. So why does this pill spark so much disagreement? Is it a safety issue, or does it reflect deeper attitudes toward female sexual desire? The answer is far from simple.
Women's Libido Medication Returns to Market
A small tablet with a big journey
To understand the current situation, we need to look back further than this week. Addyi, whose generic name is flibanserin, became the first medication authorized to address diminished sexual desire in women. It faced FDA rejection twice—in 2011 and 2013—before finally receiving approval in 2015, aided by the advocacy of a coalition called Even the Score, comprising women's health and rights organizations.
So why did it take so long to become commercially available? Valeant Pharmaceuticals, which had acquired Sprout Pharmaceuticals (Addyi's developer), became embroiled in a distribution controversy unrelated to Addyi—a scandal that eventually dragged down the entire company, according to Bloomberg. In December 2017, after a legal dispute, Valeant returned Sprout to its former CEO and the drug's initial advocate, Cindy Eckert.
Six months after that handover, Addyi can now be prescribed by clinicians certified under a risk evaluation and mitigation strategy, including doctors accessible via a telemedicine service linked from the drug's official site.
What is Addyi designed to achieve?
The FDA granted approval for Addyi to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. These women find their low libido distressing, and the condition isn't attributable to medical or mental health problems, relationship troubles, or side effects from other drugs or substances.
Now is an appropriate moment to clarify the 'female Viagra' label—a media invention that doesn't accurately characterize the drug. As Dr. Jessica Shepherd, an OB-GYN, explains to SheKnows, Viagra boosts blood flow to the penis, whereas Addyi acts on brain neurotransmitters. 'It's an erection problem versus a desire problem,' she notes.
Put simply, Addyi addresses a condition that goes beyond a purely physical challenge. The two drugs target distinct problems with different mechanisms. Addyi functions similarly to an antidepressant—indeed, it was originally developed for that purpose—by modulating brain chemicals that lower inhibitions and heighten arousal.
What makes Addyi such a contentious drug?
This is where the discussion grows more nuanced, moving beyond mere safety and effectiveness to touch on deep-seated sexism and paternalism within the medical field.
Whether the FDA approves a medication, a doctor prescribes it, or a patient opts to take it, a critical consideration is whether the advantages surpass the potential harms. Every prescription drug has side effects—that's standard. Yet for a drug to be deemed acceptable, its benefits must exceed its risks and adverse effects.
Per the FDA, Addyi's frequent side effects include dizziness, drowsiness, nausea, fatigue, insomnia, and dry mouth. These are hardly unique—they appear in numerous other drugs as well.
Addyi carries a 'black box warning'—the FDA's strongest alert for serious or fatal risks—instructing patients not to consume alcohol while taking it. Shepherd considers this 'a bit excessive,' arguing that many medications could warrant similar warnings if scrutinized for alcohol interactions. Interestingly, Eckert points out that Canadian packaging didn't include any alcohol restriction.
Recognizing the importance of female sexual desire and satisfaction
Yet side effects weren't the only worry. The 2015 FDA approval also sparked doubts about the drug's actual efficacy. This is where the complexity deepens. Unlike Viagra, which provides an obvious indicator of effect—an erection where none was possible—female sexual desire lacks a comparable measurable sign.
This problem is compounded by the reality that, even in 2018, many still fail to view women's sexual pleasure as worthwhile or valid. If the benefit—here, female desire and enjoyment—is assigned zero value in a risk-benefit calculation, then, as Eckert says, 'any risk becomes unacceptable.'
Naturally, Viagra and similar erectile dysfunction medications also have side effects. The distinction lies in society's trust in men to make their own healthcare choices.
Similarly, many individuals—including physicians—lack a proper understanding of how sexual desire functions. When a woman reports low libido, she's frequently advised to purchase lingerie, read Fifty Shades of Grey, or simply relax. Yet, as Eckert explains, research has shown since 1977 that low desire has a neurological foundation.
Let's be clear: A healthy libido doesn't imply being aroused and ready around the clock; desire naturally fluctuates. Just as antidepressants aim to restore a person to a 'normal' mood rather than induce euphoria, Addyi seeks to help women regain the level of sexual desire that was typical for them before.
Eckert states, 'The loss of libido creates personal anguish and strains relationships. It seemed illogical to me that these women couldn't access a medical treatment that actually exists.'
This brings us to the question of how we measure Addyi's effectiveness. A 2016 study in JAMA Internal Medicine found that women taking the drug reported an average of 4.4 'satisfying sexual events' per month, compared to 3.7 for those on placebo and 2.7 before the trial. That might seem a modest increase, but Eckert argues that the FDA's approval endpoints—such as 'satisfying sexual experiences'—are male-oriented metrics applied to a female drug, so the results aren't meant to be revolutionary.
Furthermore, Eckert notes that examining data from the roughly 11,000 women in Addyi's clinical trials reveals anecdotes like a woman experiencing a sexual fantasy for the first time in years and subsequently texting a flirtatious message to her partner. Is that a quantifiable orgasm? No. Yet for individuals who had lost the capacity to fantasize, it represents meaningful progress.
Who is a suitable candidate for Addyi (if anyone)?
As an active OB-GYN, Shepherd recognizes 'the value of having such a tool' available for patients diagnosed with hypoactive sexual desire disorder.
She states, 'I believe the advantages exceed the dangers, and it deserves to be available again because we have very few options to address this condition.'
However, Shepherd cautions that Addyi is not a cure-all for every sexual problem—it specifically targets hypoactive sexual desire disorder, a condition with defined symptoms in the Diagnostic and Statistical Manual of Mental Disorders. It's not a wonder drug that transforms a naturally low-libido person into a Samantha Jones.
Beyond correcting misunderstandings about the medication, Eckert also aims to improve access. She has reintroduced telemedicine consultations with physicians and reduced the price to her initial levels: $25 per month for insured patients and a cap of $99 per month for those paying out-of-pocket (after Valeant had substantially increased the cost).
Shepherd adds that even for those who would never use Addyi, the public discussion about female sexual desire itself yields benefits—particularly if it helps diminish the guilt or embarrassment often associated with these topics.
In the end, the core issue is trusting women to make informed choices regarding their bodies and medical care. No medication is universally effective or free of side effects—but at least women now have an additional option to pursue a fulfilling sex life, along with a reason to discuss it openly.
*This article uses 'female' and 'woman' to refer to individuals with a vagina, vulva, and uterus, and 'male' and 'man' for those with a penis, acknowledging that not everyone with female anatomy identifies as a woman and not all women have such anatomy.
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