Newly approved ‘female Viagra’ – drug to restore sex drive – has women both hot AND bothered

Women suffering from a decrease in sexual desire may now have what could be the equivalent of Viagra for men.

The Food and Drug Administration approved a new drug on Friday that would reportedly help premenopausal women who are affected by what is known as hypoactive sexual desire disorder, according to a news release.

(Image: FDA Flickr)

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment,” a press release stated from Hylton V. Joffe, the director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products.

“Today’s approval provides women with another treatment option for this condition,” Joffe said, referring to Vyleesi, the drug that activates the pathways in the brain connected to sexual desire.

“As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction,” Joffe added.

The move sparked criticism from several women’s health advocates.

According to the FDA new release:

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship or the effects of a medication or other drug substance. Acquired HSDD develops in a patient who previously experienced no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.

 

“Most women who come into my office have no idea that there’s this condition … and that they are one of millions,” Sheryl Kingsberg, division chief of Behavioral Medicine at University Hospitals Cleveland Medical Center, told CNN.

“No matter how good my psychotherapy, how good the relationship, how good their beliefs and values are about sexuality being healthy, there are a huge number of them that I cannot help because there is an underlying biologic issue,” she added.

The drug, which will be available in September, is injected at least 45 minutes before anticipated sexual activity in an area under the skin of the abdomen or thigh and patients are advised to limit the use to one dose within 24 hours and no more than eight doses per month.

One significant way Vyleesi differs from Addyi, its chief competitor, is that it does not restrict alcohol use and has mild side effects such as “nausea and vomiting, flushing, injection site reactions and headache.”

The FDA granted AMAG Pharmaceuticals the approval for the new medication for low female libido, bremelanotide, which is being marketed as Vyleesi. But some think the use of drugs and chemistry is not the solution.

“Our best sex lives aren’t brought to us by our local pharmacist,” Lux Alptraum contends in an opinion piece published by NBC News. “They’re brought to us by a deep, intimate understanding of our desires, our body’s capacity for pleasure, and the ways in which we enjoy being intimate with other people.”

“It’s important for people to consider whether their vision of ‘normal’ and correct sexuality is one that’s based in their own desires, or whether they’re responding to a message being imposed upon them by a society that treats sex and sexual pleasure as a one-size-fits-all experience, rather than something highly individual and personal,” Alptraum wrote.

Taking a pill (or, in the case of bremelanotide, a shot) doesn’t provide the answer to any of those questions,” the author argued, urging caution in the search for a “pink Viagra.”

The National Women’s Health Network expressed its disappointed in the FDA approval, and urged women to “avoid using the drug until more is known about its safety and effectiveness.”

We’re frustrated that the FDA has allowed this product on the market without providing women with the assurance they deserve that it is safe and effective,” Cynthia A. Pearson, NWHN Executive Director, said in a statement. “Women deserve better.”

Friday’s announcement of the FDA approval was already sparking mixed reactions on social media ranging from concerns about side effects to why women need to inject a drug while men get to swallow a pill.

Frieda Powers

Senior Staff Writer
[email protected]

Originally from New York, Powers graduated from New York University and eventually made her way to sunny South Florida where she has been writing for the BizPacReview team since 2015.
Frieda Powers

Comments

Latest Articles