It’s NOT a “pink Viagra”

Lots of my sufferers, colleagues, buddies, and even neighbors have requested me concerning the new drug flibanserin (model title Addyi). Simply this previous Tuesday, the FDA accepted this drug for remedy of low sexual want in ladies. Flibanserin has generated extra questions, feedback, and media inquiries for me than I’ve ever skilled in my 20-year profession as an Ob/Gyn. Whereas there are a number of medicines that enhance sexual operate in males (together with Viagra, probably the most well-known one), flibanserin is the primary drug ever accepted by the FDA to enhance sexual operate in ladies. Listed here are what I take into account the related info and information about flibanserin, and the recommendation I give my sufferers.

Initially, it’s not a “pink Viagra.” Viagra (sildenafil) treats erectile dysfunction in males by enhancing blood circulate to the penis by inhibiting the enzyme nitric oxide synthase. In distinction, flibanserin is believed to work by growing the discharge of the neurotransmitter hormones dopamine and norepinephrine, whereas lowering serotonin launch within the space of the mind that regulates sexuality. Viagra is taken simply earlier than having intercourse, whereas flibanserin must be taken day by day. Flibanserin is just accepted for pre-menopausal ladies. It has been proven to barely enhance sexual satisfaction in some ladies (some greater than others).

The potential negative effects embrace low blood stress, nausea, and fainting. Girls mustn’t drink alcohol or use contraception tablets whereas taking it as a result of they will worsen the negative effects. After all, some ladies could resolve these necessities and negative effects are simply not price it, since they are often fairly large drawbacks for a drug designed to enhance the intercourse lives of premenopausal ladies.

In my observe, ladies of all ages have questions and considerations about intercourse and sexuality. Most girls seeing an Ob/Gyn do. These questions usually come up proper after a girl has a child, throughout perimenopause, and later in life as properly. Girls’s sexuality may be very complicated, and is affected by mind chemistry, temper, relationships, medicines, and well being standing (of each companions). As a doctor, if a girl involves me reporting considerations with sexuality, I begin by assessing her bodily and psychological well being (despair is a typical reason behind lack of curiosity in intercourse), after which examine to see if she is on medicines that may have an effect on curiosity in intercourse. Widespread medicine culprits are contraception tablets, blood stress tablets, and antidepressants. Subsequent, I ask about her relationship. If all of these appear to be okay, I then examine on her stress stage and her schedule.

Usually, I discover that {couples} who’re fighting sexuality haven’t put aside any time and power for his or her relationship. I ask, “For those who and your companion had been alone on a tropical island, and also you had no worries or schedules, would you be thinking about intercourse?” If the reply is sure, we work on methods for prioritizing and carving out time for the connection. If the reply is not any, then I’m left with the prognosis of hypoactive sexual want dysfunction (also referred to as HSDD). I usually attempt to ship these {couples} to intercourse therapists, however these specialists are few and much between, and are sometimes costly. As well as, many {couples} are too embarrassed to comply with by means of. This subgroup of girls with hypoactive sexual want has been vexing to me as a result of I’ve largely not been in a position to assist them. They’re usually in wholesome relationships, and but they haven’t any want, intercourse drive, or response to sexuality. I attempt to discover all choices with these ladies; nevertheless, so far, there has not been a medical possibility. Flibanserin is meant for this group of girls.

The approval of flibanserin took a few years, and adopted two prior rejections by the FDA as a result of it was thought that the negative effects had been too sturdy for the modest profit in sexual operate. In the latest FDA evaluation, the drug’s sponsor offered further security information that confirmed the absence of next-day driving impairments, a comparability of flibanserin’s negative effects alongside different merchandise already accepted by the FDA, and an evaluation confirming that the negative effects had been extra pronounced when flibanserin was taken with alcohol. Controversy arose as a result of solely two of the 25 volunteers for the alcohol examine had been ladies. So as to add to the controversy, an advocacy group who needed flibanserin accepted, referred to as “Even the Rating,” instructed there was gender bias within the FDA evaluation course of.

One large fear many individuals have, myself included, is the potential for flibanserin for use off-label, which means that it may very well be utilized in a broader inhabitants of girls for whom it wasn’t accepted. For instance, this inhabitants may embrace older ladies, these with medical points, and people combining its use with alcohol or contraception tablets. Use of flibanserin by ladies in any of those classes can improve the chance and severity of negative effects. One other fear is whether or not the modest enchancment in sexual operate is de facto well worth the potential threat of negative effects. My plan is to debate this with ladies who may profit from it, and allow them to resolve. Who am I to be the ultimate arbiter of what’s necessary for a girl’s high quality of life? A wholesome doctor and affected person relationship ought to permit for any such dialogue and joint decision-making.

I welcome these conversations and this controversy. Feminine sexual dysfunction is a crucial unmet medical want and deserves acceptable analysis and remedy choices. The issue of hypoactive sexual want and arousal, particularly for ladies, is actual. Whether or not flibanserin will assist the subgroup of girls for whom it’s acceptable, and the diploma to which it improves sexual operate, stays to be seen. I believe the impact is small, and the group for whom it may be safely utilized is restricted, however at the very least it’s a step in the suitable route. My recommendation is to proceed with warning and comply with the recommendation of the FDA to the letter on this one. Discover all non-drug choices that may provide help to create a satisfying intercourse life — scale back stress, handle your well being, examine together with your doctor in your medicines and well being standing, and prioritize time to your relationship.

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