‘Pink Viagra’ Approved By FDA: What Does This Mean For Women?

After years of men having a medication that they can use when experiencing low-libido or other causes of erectile dysfunction, the United States Food and Drug Administration has finally approved a similar medication for women to use as of late today. It was reported by the Inquisitr yesterday that the approval was pending and hanging in the balance. The FDA’s green light on the drug flibanserin, often known by the nickname “pink Viagra,” reverses two earlier decisions by the FDA to reject the medication as a treatment for hypoactive sexual desire disorder, also known as HSDD, according to The Los Angeles Times. The reasons for HSDD may be multifactorial and sometimes unknown: hormonal changes, life tension, other medication side effects, and poor body image are just a few of the reasons known that a woman may experience low libido, but those reasons do not classify a women as having HSDD, because her low libido can be explained by other physical or psychological causes.

The decision came amidst growing public outcry that while men have several medications available to them to enhance sexual performance or treat dysfunction, women do not nearly have as many options. While low libido in women does not make sexual intercourse impossible the way that erectile dysfunction may for men, it certainly can have significant psychological and relationship impacts on the female and her sexual partner.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that the FDA is dedicated to the safety of medications, including flibanserin, which can actually be used to treat sexual dysfunction in males and females.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option. We are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

Women with low sex drive may be possible candidates for therapy of flibanserin, which will be marketed under the trade name Addyi, if they do not have other explanations for low libido and are wishing to regain sexual desire. Clinical trial data presented to the FDA showed that compared with study participants who got a placebo medication, pre-menopausal women who took flibanserin reported a modest but measurable rise in sexual desire and increased the number of “sexually satisfying encounters” they had by approximately one per month, according to The Los Angeles Times. The difficulty in these studies is qualifying what a “sexually satisfying encounter” is. It is likely different things to different people. And while one a month is not a huge amount, it may mean a great deal for a woman who is struggling to regain feelings of intimacy and sexuality.

The drug is believed to work by manipulating the release of serotonin, a mood chemical in the brain closely associated with sexuality, sleep, appetite, and other mood-related human behaviors. However, the exact mechanism of action is not understood, which is common with many mood-related medications that manipulate serotonin.

While the drug has been deemed safe for general public consumption, that does not mean it is safe for all individuals. In approving the drug on Tuesday, the FDA acknowledged it had continuing concerns about Addyi’s safety. The FDA announced it had directed Sprout, the pharmaceutical company who has the rights to Addyi, to conduct three additional tests of the drug in women who drink alcohol. Debates over the drug’s safety, as reported by Yahoo News, have largely centered on its potential for inducing dizziness, lightheadedness, or fainting caused by a sudden drop in blood pressure which can be raised exponentially when combined with alcohol.

The blood pressure concern is highest in those patients who are taking the drug and are heavy consumers of alcohol, or take CYP3A4 inhibitors, a classification of medications that includes common antifungal medications, antibiotics, HIV drugs, and some blood-pressure medications. These will warnings will be clear on the prescription medication, but several factors, including low literacy levels, may make some women more vulnerable.

While there are currently twenty six medications approved to enhance male sexual performance and desire, this is the first for women. What are your thoughts on the approval of this drug?

[Photo Courtesy of the AP/Associated Press]

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