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.
Let’s be clear here. There is no similarity between this drug and Viagra®. Viagra fixes a physical issue; lack of blood flow to male sex organs. 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 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. Earlier this month, the agency followed that advice.
The Evidence Is Underwhelming at Best
In clinical trials, the drug showed VERY modest benefits. 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®. 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.
Is Lack of Desire all in Our Heads??
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?
I think not.
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.
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. I do have concerns, though, that women will feel pressured by their partners to try it or that they’ll feel like they now need to live up to some numerical standard that doesn’t match their natural desire. And as a health care provider, I worry that prescribers may not take the time to have an in-depth discussion about the dangers of mixing flibanserin with alcohol.
Let’s Get to the Root Cause
In my mind, the best solution to a lack of sexual desire involves non-drug approaches, like therapy and mind-body techniques. We need to get our partners on board and engaged in the solution and address the root causes. There is no “mojo miracle” quick fix. The use of mind-altering drugs to increase libido simply continues society’s pathologizing of normal behavior in women. The FDA’s approval of flibanserin creates a potentially dangerous situation and does women a disservice in the long run.
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About Dr. Anna
Dr. Anna Garrett is a pharmacist and menopause expert who helps women who are struggling with symptoms of perimenopause and menopause find natural hormone balancing solutions so they can rock their mojo through midlife and beyond. But her clients would tell you that her real gift is helping them reclaim pieces of themselves they thought were gone forever.
Dr. Anna offers a complimentary 30-minute Get Acquainted Call to anyone who’d like to learn more about working 1-1 with her. You can schedule that at your convenience by clicking here.
Please contact her at dranna@drannagarrett.com.
