Home Chemistry ‘Viagra for women’ – is it safe, and does it even work?

‘Viagra for women’ – is it safe, and does it even work?

Viagra and other ED treatments were a watershed moment in human sexual health – millions of men could (and have) take advantage of the “little blue” pill to receive a new lease on their sex lives. Though men tend to be the arbiters of sexual health advancements, other questions soon arose. What could be done for women frustrated not with their lack of ability to have sex, but a lack of desire? And, certainly, what might men be able to do to help their significant others want to get it on more often? A drug called flibanserin claimed to be the answer, but has been rejected twice by the FDA. It’s being reviewed once again on Thursday, but the same questions remain – is it safe for use, and does it work in the first place?

A campaign known as “Even the Score” is pushing for approval of a drug to treat sexual dysfunction, and has the backing of multiple prominent women’s organizations. Their biggest question is, given that the FDA has approved 25+ drugs for male sexual dysfunction but none for women, does the FDA have a gender bias? The FDA categorically denies this, and other public health experts echo the sentiment.

“I don’t think there is anything sexist about denying approval for drugs that don’t have an adequate risk-to-benefit ratio,” Thea Cacchioni, an assistant professor of women’s studies at the University of Victoria in British Columbia told the New York Times.

Risk-to-benefit ratio appears to be the cornerstone on which the FDA has built its house of denial for flibanserin and other female-oriented sexual enhancement drugs. Some psychologists believe that Sprout, the company that manufactures flibanserin is using medical issues as a red herring for profit. Essentially, it’s the belief of many that problems with sexual desire in women result from psychological or relationship issues, not with chemical imbalances. The same could be said for some men’s inability to “perform,” however, which would seem to fuel Even the Score’s accusations of bias.

Muddying the waters is the fact that the American Psychiatric Association no longer lists hypoactive sexual desire disorder, the condition flibanserin is designed to treat, in its manual of mental health disorders. The same FDA committee that initially rejected flibanserin even went so far as to say that low sexual desire is a real problem, and that drugs should be produced to combat it. Sexual health practitioners point to patients who, regardless of the root causes of their low desire, feel frustrated and even worry they’ll jeopardize their relationships due to a lack of desire to initiate (or even participate in) sex.

Flibanserin supposedly works by decreasing serotonin levels in the brain while raising levels of two other neurotransmitters, dopamine and norepinephrine. Its effectiveness is questionable, and likely the reason it’s been rejected thus far. One study that measured the number of “satisfying sexual encounters” per month on women taking the pill versus a placebo produced statistically significant results, but they weren’t necessarily meaningful. Some women have reported dramatic improvements with the drug, however, and some medical experts believe a monthly questionnaire rating desire would be a better measure of the drug’s success. By that measure, flibanserin clearly outperformed a placebo in most trials.

As for side effects, Even the Score claims they’re mostly benign, including things like sleepiness and dizziness. Viagra, on the other hand, is known to cause more dangerous side effects like blindness and penile rupture, if taken improperly.

“The implication is that men can be trusted to make a rational decision of risk versus reward and women can’t,” said Susan Scanlan, chairwoman of Even the Score. So, which is it? Are flibanserin’s modest benefits not enough to outweigh its modest risks, or is this potentially an indicator of bias in the FDA? Thursday’s ruling may shed some light.