Sex Drug for Women Stirs Up Controversy in Medical Community

 Just don’t call the new medication for women’s low desire for sex 'female Viagra.

There is some good news out about how women’s sexuality, long overlooked in the medical community, is treated now. Amid much hype and interest, the U.S. Food and Drug Administration (FDA) approved Vyleesi (bremelanotide), an injection designed to improve female sexual interest arousal disorder (FSIAD) — also known as hypoactive sexual desire disorder — in premenopausal women.

Is Sexual Interest Arousal Disorder the Same as Sexual Desire Disorder?

Formerly called hypoactive sexual desire disorder (HSDD), the term for a lack of desire for sexual activity was recently updated in the Diagnostic and Statistical Manual of Mental Disorders (DSM–5). The disorder is when women are distressed by the fact that they have little to no desire for sexual acts and the lack isn’t due to medication, disease, relationship problems, or psychological issues. The low desire is chronic (six months or longer), present at all times (not just during certain situations), and is associated with personal distress. (The distress must be the woman’s, and not the partner’s. There is nothing wrong with a woman with low desire who isn’t upset with the status. There is a difference between dysfunction and disinterest.)

According to earlier research published in the journal Pharmacotherapy, nearly 10 percent of women probably experience female sexual interest arousal disorder.

New Drug Helps Validate Women’s Sexual Experiences

“The whole concept of minimizing women’s sexual health issues is important. In the past, if women had sexual problems, they were just told they were hysterical. Now their issues are coming to the forefront, and at least the release of Vyleesi may indicate that women’s sexual health is becoming more of a priority. It’s empowerment for women that they now have choices and options,” says Michael Krychman, MD, executive director of the Southern California Center for Sexual Health in Newport Beach.

Leah Millheiser, MD, director of the female sexual medicine program at Stanford Health Care in California, adds, “It is a coup for women that the FDA is recognizing chronically low libido as an important health issue.”

New Libido Drug Is Not a Cure for All Sexual Problems

There has been some controversy, however, over the release of Vyleesi, in that it may promise more than it can deliver. First, to be clear, the injections are not a silver bullet. Women’s sexuality is a complex interplay of medical, psychological, situational, and relationship status.

“Female sexual health and wellness are multifactorial. Vyleesi provides one facet to help but it’s important to appropriately assess the woman first. If the woman has complaints, she needs to be offered an intervention: Not just medical, but sometimes also psychological input and counseling are also very appropriate. In my clinical experience, women can benefit from medical intervention and some sort of counseling as well,” says Dr. Krychman.

You May Still Need Sex Counseling to Get Back on Track

Reality check: You will still have to work on your relationship. Women and their partners have to remember that if they have had long-term concerns with desire, they may need help via sex therapy on getting back to intimacy. “It's challenging to go from 0 to 10. You have to relearn sexual trust and intimacy. Simply giving yourself a shot is not necessarily going to be a panacea. Vyleesi improves desire, but don't expect to feel like you're in your sexual prime again. It’s a subtle improvement, but that might be enough to improve intimacy and sexual self-esteem,” says Dr. Millheiser. 

Vyleesi Is Not Appropriate for Women With Low Libido Who Do Not Have Arousal Disorder

Vyleesi is only for premenopausal women with female sexual interest arousal disorder. For women who have low sexual desire — and would like to have more — their first stop should be to a clinician who can assess where the issue is. If sexual dysfunction is ruled out, making behavioral changes is more effective than medication. “As you age, spontaneous sex is harder to come by. Making time, relationship and sex counseling, finding private time, getting into a new environment, sex toys, and working on body image can all help. Women may not start out with spontaneous desire, but can develop responsive desire in the act,” says Millheiser, who also recommends “pregaming.” Self-stimulate, or read or watch something arousing, so you can develop responsive desire prior to engaging with your partner. 

Not Female Viagra: Vyleesi Does Not Work the Way Viagra Does

There is also a prevalent misconception that Vyleesi, the second medication of its kind to come to market following the release of Addyi (flibanserin), is a female Viagra (sildenafil), referring to the male medication for erectile dysfunction. Vyleesi works on desire, while Viagra works on arousal. “Clinicians really want to move away from comparing women’s drugs with men’s. Viagra increases blood flow to the penis but men have to have desire in order for it to work. Vyleesi alters neurochemicals in the brain so women can feel desire,” says Millheiser.

Has the Public Been Provided Enough Information About the Drug?

The National Women's Health Network, a consumer activist group, says that the FDA rushed Vyleesi to market too soon. In a statement about the approval, Cynthia Pearson, executive director, said, “The National Women’s Health Network is disappointed in the U.S. Food and Drug Administration’s (FDA) decision to approve the drug bremelanotide (brand name: Vyleesi) and urges women to avoid using the drug until more is known about its safety and effectiveness. Women simply do not have enough information to make an informed decision about whether the drug is safe and effective. The FDA did not call on their advisers to review the drug publicly, and the sponsor has not yet published full clinical trial results. The limited data that has been published leaves many important questions unanswered. For example, it appears that hundreds of women enrolled in the pivotal trials were not included in the company’s presentation of the results. What happened to those women?”

The organization also points out the potential side effects: severe nausea, and skin and gum darkening, which did not go away after stopping treatment in about one-half of cases.

There Are Concerns About Side Effects, Safety, and Effectiveness

“We respect the ability of women to make good decisions if they have good information. We are not saying side effects are a reason why women shouldn’t use it; the issue is how much do we know? Can you get enough information to make an informed decision? A very determined person could get more info by reading the detailed label on the FDA website, but it still feels like the FDA didn’t do women good service here by the rush,” says Pearson, adding, “I’ll be surprised if it takes a very big place in the arsenal. It is not very effective and makes a lot of women very uncomfortable. My prediction is it is going to be something of a flop.”

Krychman disagrees with this assessment: “The product has been extensively studied. I think it’s appropriate for the FDA to make its own judgment. They evaluated and assessed the clinical program, which was very robust, and they have a competent group of advisors.”

Millheiser concurs, “The drug company behind Vyleesi has provided sufficient data on safety and efficacy. If there hadn't been, the FDA would not have approved it.”

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