It is not a "pink Viagra"

Many of my patients, colleagues, friends and even neighbors ask me about the new drug flibanserin (brand name Addyi). Just last Tuesday, the FDA approved the drug for the treatment of hypoactive sexual desire in women.

Flibanserin generated more questions, comments and questions from the media for me that I have never experienced in my 20 year career as an obstetrician / gynecologist. Although there are several drugs that enhance sexual function in men (including Viagra, the most famous), flibanserin is the first drug approved by the FDA to improve sexual function in women. Here are what I consider the relevant facts and data on flibanserin and the advice I give to my patients.

First, it is not a "pink Viagra." Viagra (sildenafil) for erectile dysfunction in men, improving blood flow to the penis by inhibiting nitric oxide synthase enzyme. However, it is estimated that the acts of FLIBANSERIN by increasing the release of dopamine and norepinephrine hormones neurotransmitters, while decreasing the release of serotonin in the brain area regulating sexuality. Viagra is taken just before sex, while flibanserin must be taken every day. Flibanserin is approved for pre-menopausal women. It has been shown that slightly improved sexual satisfaction in some women (some more than others).

Possible side effects include low blood pressure, nausea and fainting. Women should not drink alcohol or birth control use while taking as it may aggravate side effects. Of course, some women may decide these requirements and side effects are not worth it, because it can be pretty big inconvenience for a drug intended 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 who see an obstetrician / gynecologist do. These questions often come right after a woman has a baby, during perimenopause, and later in life too. Women's sexuality is very complex and is affected by brain chemistry, mood, relationships, drugs and health status (torque).  

As a doctor, if a woman comes to my attention their concerns to sexuality, I begin by assessing their physical and mental health (depression is a common cause of loss of interest in sex), and then check to see if she takes medication that may influence the interest in sex. Guilty of common drugs are birth control pills, pills for high blood pressure and antidepressants. I then asked about their relationship. If all this seems to be going well, so I looked in your stress level and your schedule.

I often find that couples who are struggling with sexuality have not neglected any time and energy to your relationship. I ask, "If you and your partner were alone on a tropical island, and he had no concerns or schedules, would you be interested in sex?" If the answer is yes, we are working on strategies to prioritize and time to build the relationship. If the answer is no, then I prefer disorder diagnosis of hypoactive sexual desire disorder (also known as DSH).  

I often try to send these couples to sex therapists, but these experts are rare, and are often expensive. In addition, many couples are too embarrassed to go ahead. This subgroup of women with hypoactive sexual desire was confusing to me mostly because I have not been able to help. They are generally in a healthy relationship, and not have the desire, sexual desire, or the answer to sexuality. I try to explore all options with these women; However, to date there has not been a medical option. Flibanserin is to this group of women.

The approval of flibanserin took many years, and after two previous rejections by the FDA because he thought that the side effects were stronger than the modest profit in sexual function. In the latest revision of the FDA, the sponsor of the drug provides additional safety data that showed the absence of impaired driving following day, a comparison of side effects of flibanserin, and other products that have already approved by the FDA, and the analysis confirms that the side effects were more pronounced when flibanserin is taken with alcohol. The controversy arose because only two of the 25 volunteers for the study of alcohol were women. To add to the controversy, an advocacy group that wanted flibanserin approved, called "equalize" he suggested was sexism in the process of FDA review.

A major concern that many people, including myself, is the potential of flibanserin to be used off-label, which means it could be used in a larger population of women for whom it was not approved. For example, this population could include older women, people with medical problems, and combining the use of birth control pills or alcohol.  

The use of flibanserin for women in any of these categories can increase the risk and severity of side effects. Another concern is whether the modest improvement in sexual function worth the potential risk of side effects. I plan to discuss with women who might benefit, and let them decide. Who am I to be the final arbiter of what is important to the quality of life of a woman? A doctor-patient relationship in good health should allow this type of discussion and joint decision making.

I welcome these discussions and controversy. Female sexual dysfunction is a significant unmet medical need and deserve research and treatment options. The problem of hypoactive sexual desire and excitement, particularly for women, is real. Either flibanserin help the subset of women for whom it is appropriate, and the extent to which improves sexual function, remains to be seen.  

I suspect that the effect is low, and the group that can be safely applied is limited, but at least it is a step in the right direction. My advice is to proceed with caution and follow the FDA's advice to the letter in this case. Explore all non-pharmacological options that can help create a fulfilling sex life - reduce stress, take care of your health, talk to your doctor about medications and health status, and to give priority in their relationship.
By: Hope Ricciotti