Exploring the Controversy of the Pink Pill

“I feel like a new woman on this drug,” one woman who took the pill shares in the documentary’s trailer. But the road to approval wasn’t easy. It took entrepreneur Cindy Eckert, founder of Sprout Pharmaceuticals, which manufactures the drug, 10 years to get the green light. It was rejected by the Food and Drug Administration twice — and when it was approved, it had a black box warning, which has since been removed. The film examines the systemic bias against women’s care, including concerns that women would “not make good choices” on the medication. There haven’t been, at least publicly, similar concerns about medications for male erectile dysfunction. “How do you take on the government for women's sexual pleasure?” Eckert says in the trailer.

• Some pink pills combine herbal extracts like ginseng or maca for effects.
• They are popular in wellness circles for enhancing intimacy and confidence.
• Research on pink pills' long-term safety is limited; caution is advised.
• Available through online stores, pharmacies, or clinics in some regions.

“You lean right into it and say, ‘This is the conversation we're going to have.'” The Pink Pill: Sex, Drugs and Who Has Control is now streaming through DOCNYC. The Food and Drug Administration’s recent approval of a marginally effective drug to enhance the sexual drive of women with low libido raises a lot of questions. We will probably never know whether the agency made a purely scientific judgment or whether a campaign called “Even the Score” unduly influenced it.

This campaign was partly financed by the manufacturer and organized with the help of one of its consultants.

It depicted the agency as gender-biased for never having approved a drug to treat sexual dysfunction in women while approving numerous drugs for men.

Finally, Addyi is a pink pill, and you often dress in pink. How did that start?

The expansion to post-menopausal women is long overdue. As a female founder in health, even when raising money for this product that has a higher prevalence than erectile dysfunction, we weren’t getting any money from Sand Hill Road [a part of Silicon Valley rife with venture capitalists]. I had built a successful company in men’s sexual health. I had seen what the standard was there. When the same standard wasn’t applied for women, I questioned it and pushed back.

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I had a six-hour, very public conversation with the FDA about this, and there was a lot of manufactured controversy—because of how we feel about women and sex. The fact is that 50% of the population goes through menopause, and we’re told, “Just relax, take a bubble bath; it’s just a transition period.” It’s literally a biological phenomenon, and we treat it by telling people to just calm down. There’s a concept in medicine that women’s ed medications symptoms are considered more likely to be psychosomatic and more likely based in emotions. It shows up in the way we treat women’s heart attacks, and that it takes longer to prescribe pain medication for women than for men. To me, the basis of that is that we believe women are entirely psychological creatures rooted in emotion, while men are biological creatures.

How is Addyi supplied (dosage forms)?

That gives us as a society extraordinary permission to dismiss what women are experiencing, because once we decide that women are emotional, any symptom women report, they’re patted on the shoulder and told to relax. We’ve created a culture of dismissal. To me, this is a litmus test for what this conversation is going to be like. Now we are saying half of the population goes through this thing called menopause. Now we are taking it, I hope, a little more seriously. There is no similarity between this drug and Viagra®. Viagra fixes a physical issue; lack of blood flow to male sex organs.

• Pink pills are part of a broader trend towards female-centered wellness.
• They can potentially enhance intimacy, confidence, and overall satisfaction.
• Unregulated products pose risks of contamination or inappropriate ingredients.
• Always verify product credentials and manufacturer reputation before purchase.

A man takes it, and presto, he’s ready to rock and roll when he and his sweetie climb out of their bathtubs at sunset. The pink pill, flibanserin, or fildena ct Addyi® (the brand name), was first developed in the 1990s for depression but failed to show significant benefit. It increases levels of dopamine and noradrenalin and reduces levels of serotonin. How this translates into increased sexual desire isn’t clear. FDA rejected the drug twice, in 2010 and 2013, because of safety and effectiveness concerns.

Still, after women told an advisory panel in June how low libido had ruined their lives, the panel recommended approval for premenopausal women.

Boxed Warnings with Addyi

It will be fascinating if this conversation is fundamentally different this time around. Addyi is a case study for whether things have actually changed. Pink is a bit of active defiance to me. When people were patting me on the shoulder, saying, ‘Oh the little pink pill,’ I recognized that in that was dismissiveness and trivialization, and that was the very conversation I wanted to have: you perceive [women’s loss of sexual desire] as weakness or unimportant, but I see it very differently. I was criticized for wearing pink and was told people wouldn’t take me seriously.

What are the serious side effects of Addyi?

But I believe you always get two choices. You either lean back away from it and distance yourself, or you lean right in toward it. I always loved pink, and never saw it as a sign of weakness. I see it as a strength to show up exactly as you are. The original version of this story mischaracterized how the drug was approved for post-menopausal women. Earlier this month, the agency followed that advice. In clinical trials, the drug showed VERY modest benefits.

What women are saying

The FDA required an additional review of data Sprout had already provided; new studies were not conducted. The new documentary, The Pink Pill: Sex, Drugs and Who Has Control, looks at the decade-long fight to bring a pill for women's sexual health to market Addyi is a pill that can improve a woman’s libido, but concerns that women would “not make good choices” on it delayed its approval The documentary explores systemic gender inequalities that work against women's sexual health It’s a small pink pill that can help women regain control of their sexual health. That’s the question explored in the new documentary, The Pink Pill: Sex, Drugs and Who Has Control. The documentary — helmed by acclaimed director Aisling Chin-Yee (No Ordinary Man, Rest of Us, Plan B) — explores the inherent gender bias in women's health through stories of real women who restored their libido by using a little pink pill, Addyi. Addyi is an FDA-approved, non-hormonal prescription medication that’s been mistakenly called “female Viagra.” But unlike that little blue pill, Addyi works in the brain, not the body — and instead of taking it before sexual activity, it’s meant to be taken daily to increase sexual desire in perimenopausal and menopausal women. In one trial, women who took the pill had an average of 4.4 “satisfying sexual experiences a month” compared with 3.7 for women given a placebo. I’m not sure 7/10ths of a “satisfying experience” is worth it for a drug that requires daily use and has the potential for side effects such as drowsiness, insomnia, nausea, extremely low blood pressure, and loss of consciousness. That list will get you out of the mood very quickly. The risks increase when patients drink alcohol or take certain medicines that interfere with the breakdown of flibanserin in the body such as Biaxin®, Ketek®, Cardizem®, and Diflucan®.

• The pink pill aims to boost women's libido and sexual satisfaction.
• It often contains ingredients like aphrodisiacs or hormonal components.
• Some pink pills are marketed as supplements; others are pharmaceutical drugs.
• Effectiveness varies; consult a healthcare provider before use.

Grapefruit juice can also have this effect. Doctors and pharmacists who will prescribe or dispense the drug must watch an online tutorial, pass a test demonstrating their comprehension, and counsel patients following FDA guidelines. In addition, the manufacturer will have to conduct three well-designed post-marketing studies to understand the interaction with alcohol better. The FDA approved Flibanserin to treat HSDD (hypoactive sexual desire disorder) or female sexual interest/arousal disorder, which the DSM-V manual list as a mental disorder. This drug approval supports the notion that women who don’t seek sexual arousal are in some way broken and need to fix themselves. Who decides the number of sexual encounters a woman should desire? And if she desires less than the “average,” does she require a diagnosis and chemical manipulation of her brain? Attempting to treat lack of sexual desire with a “pink pill” ignores the fact that a woman’s desire for sex is COMPLICATED. It’s deeply affected by everyday life stress and relationships.

There’s no pill on earth that can fix these things if they’re out of balance. Maybe a study should compare women who juggle all the day-to-day responsibilities of life with those who have a cleaning service, personal chef, and nanny. I’ll bet the ladies with the support team would be in the mood a lot more than those without. Low testosterone, body image, and self-esteem issues can also compound the problem.

How do you take Addyi?

Addyi works on neurotransmitters in the brain. If you think of other drugs that work in the central nervous system, we don’t separate populations by age in the same way. It’s the same molecule, and the same dosage as Addyi that was approved for HSDD. But there is a pattern in women’s health where we lead with a skewed point of view on the importance of factors—including the desire for sex—that are societally conditioned. The world wasn’t ready for a female Viagra.

Keys to patient success

Not only do we rule out anything a woman is experiencing as probably emotional and not medical, if there is a medical solution, we lead with its risk. The reason for that is that we have already dismissed that there is any benefit in addressing her symptoms. Read More: How to Fight Hair Loss During Menopause When Addyi first came out, there were discussions about the risks when taken with alcohol. Studies showed that some women experienced side effects including dizziness, sleepiness and nausea, and less than 2% had to discontinue Addyi because of them. So if you have one or two drinks in the evening, wait a couple of hours before taking Addyi at bedtime.

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Or if you have more than three drinks, then skip Addyi that night. We [as a society] talk about the risks of Addyi and alcohol in every article. But it’s not our call, it’s every woman’s call. She gets to weigh the benefits—more desire for sex, more interest in sex, more satisfying sexual events, and less stress over her condition. More women experience sexual dysfunction than men globally. I realize that it will be up to each individual to decide what’s right for herself, and I completely respect that. If it feels right, go for it.