It’s NOT a “pink Viagra”

Many of my patients, colleagues, friends, and even neighbors have asked me about the new drug flibanserin (brand name Addyi). Just this past Tuesday, the FDA approved this drug for treatment of low sexual desire in women. Flibanserin has generated more questions, comments, and media inquiries for me than I’ve ever experienced in my 20-year career as an Ob/Gyn. While there are several medications that improve sexual function in men (including Viagra, the most famous one), flibanserin is the first drug ever approved by the FDA to improve sexual function in women. Here are what I consider the relevant facts and data about flibanserin, and the advice I give my patients.

First of all, it’s not a “pink Viagra.” Viagra (sildenafil) treats erectile dysfunction in men by improving blood flow to the penis by inhibiting the enzyme nitric oxide synthase. In contrast, flibanserin is thought to work by increasing the release of the neurotransmitter hormones dopamine and norepinephrine, while decreasing serotonin release in the area of the brain that regulates sexuality. Viagra is taken just before having sex, while flibanserin needs to be taken daily. Flibanserin is only approved for pre-menopausal women. It has been shown to slightly improve sexual satisfaction in some women (some more than others).

The potential side effects include low blood pressure, nausea, and fainting. Women should not drink alcohol or use birth control pills while taking it because they can worsen the side effects. Of course, some women may decide these requirements and side effects are just not worth it, since they can be pretty big drawbacks for a drug designed to improve the sex lives of premenopausal women.

In my practice, women of all ages have questions and concerns about sex and sexuality. Most women seeing an Ob/Gyn do. These questions often come up right after a woman has a baby, during perimenopause, and later in life as well. Women’s sexuality is very complex, and is affected by brain chemistry, mood, relationships, medications, and health status (of both partners). As a physician, if a woman comes to me reporting concerns with sexuality, I start by assessing her physical and mental health (depression is a common cause of loss of interest in sex), and then check to see if she is on medications that can affect interest in sex. Common medication culprits are birth control pills, blood pressure pills, and antidepressants. Next, I ask about her relationship. If all of those seem to be okay, I then check on her stress level and her schedule.

Often, I find that couples who are struggling with sexuality have not set aside any time and energy for their relationship. I ask, “If you and your partner were alone on a tropical island, and you had no worries or schedules, would you be interested in sex?” If the answer is yes, we work on strategies for prioritizing and carving out time for the relationship. If the answer is no, then I am left with the diagnosis of hypoactive sexual desire disorder (also known as HSDD). I often try to send these couples to sex therapists, but these experts are few and far between, and are often expensive. In addition, many couples are too embarrassed to follow through. This subgroup of women with hypoactive sexual desire has been vexing to me because I have largely not been able to help them. They are typically in healthy relationships, and yet they have no desire, sex drive, or response to sexuality. I try to explore all options with these women; however, to date, there has not been a medical option. Flibanserin is intended for this group of women.

The approval of flibanserin took many years, and followed two prior rejections by the FDA because it was thought that the side effects were too strong for the modest benefit in sexual function. In the most recent FDA review, the drug’s sponsor presented additional safety data that showed the absence of next-day driving impairments, a comparison of flibanserin’s side effects alongside other products already approved by the FDA, and an analysis confirming that the side effects were more pronounced when flibanserin was taken with alcohol. Controversy arose because only two of the 25 volunteers for the alcohol study were women. To add to the controversy, an advocacy group who wanted flibanserin approved, called “Even the Score,” suggested there was gender bias in the FDA review process.

One big worry many people have, myself included, is the potential for flibanserin to be used off-label, meaning that it could be used in a broader population of women for whom it wasn’t approved. For example, this population could include older women, those with medical issues, and those combining its use with alcohol or birth control pills. Use of flibanserin by women in any of these categories can increase the risk and severity of side effects. Another worry is whether the modest improvement in sexual function is really worth the potential risk of side effects. My plan is to discuss this with women who might benefit from it, and let them decide. Who am I to be the final arbiter of what is important for a woman’s quality of life? A healthy physician and patient relationship should allow for this type of discussion and joint decision-making.

I welcome these conversations and this controversy. Female sexual dysfunction is an important unmet medical need and deserves appropriate research and treatment options. The problem of hypoactive sexual desire and arousal, especially for women, is real. Whether flibanserin will help the subgroup of women for whom it is appropriate, and the degree to which it improves sexual function, remains to be seen. I suspect the effect is small, and the group for whom it can be safely applied is limited, but at least it’s a step in the right direction. My advice is to proceed with caution and follow the advice of the FDA to the letter on this one. Explore all non-drug options that can help you create a satisfying sex life — reduce stress, take care of your health, check with your physician on your medications and health status, and prioritize time for your relationship.