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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