Female Viagra :: Hit or Miss?

Ladies, we now have a drug to "improve" our libido with the announcement on Tuesday that the Food and Drug Administration has given the big thumbs up to Addyi, (aka female Viagra) the first prescription drug to enhance sex drive.

The drug, known as flibanserin, works by changing the balance of brain neurotransmitters like dopamine and serotonin and will be available from October for the 10% of premenopausal women (aged 20-49) in the US who experience hypoactive sexual desire disorder (HSDD). Women with HSDD have low sex drive that causes them distress.

I hate to throw a spanner in the works but this little pink pill seems to be a little shifty. It’s twice been rejected by the FDA, and yet the regulatory giant has now given it the big fat tick with seemingly little improvement to the marginal effectiveness and negative side effects (nausea, dizziness and fainting), which deemed it unsafe and ineffective the first and second time around.

Some are saying the FDA may have cracked under the pressure from feminist lobbying groups, most notably Even the Score (who are paid by the maker of Addyi, Sprout Pharmaceutical) who demanded more drugs to address female sexual dysfunction.

The big fat question mark seems to be whether the benefits outweigh the risks. The biggest risk is Addyi’s intolerance to alcohol. When taken with alcohol there is a high likelihood of experiencing dangerously low blood pressure and then fainting. And unlike some of the other drugs on the market, such as Viagra, this pill must be taken on a daily basis, so who is going to abstain from alcohol for a marginal improvement in sex drive? And then there’s the cost, patients are likely going to have to fork out $400/month or $75 per month for those that are insured.

I am by no means a medical expert and if you read the umpteen articles and opinion pieces that have circulated since the FDA announcement, there does seem to be some strong arguments for both sides. Some say it is unsafe and not worth the risk, others say it’s revolutionary and could improve the well-being of many (see below for some quotes from medical professionals taken from this article inTime). Only time will tell but one thing is for sure, it needs much more rigorous and independent testing. And while everyone’s busy arguing, I’ll just stick to using vibrators, dressing up in lingerie andmeditating in order to achieve my sexual satisfaction.

“I am very opposed to the drug and have been since it first went to the FDA in 2010 and it was rejected. Then it was rejected a second time. The drug hasn’t changed, the data hasn’t changed, and my opinion hasn’t changed. I think it’s a disaster. It’s unsafe and it doesn’t work. That is all a drug is supposed to do. Work and be safe. The third strike is the illegitimate means by which the company [Sprout Pharmaceuticals] tried to distract the FDA by honing in on this completely erroneous accusation of sexism. The campaign is totally inappropriate.”

—Leonore Tiefer, clinical associate professor of psychiatry at NYU School of Medicine.

“Flibanserin is a game changer for women with hypoactive sexual desire disorder. I see it as one of the top health innovations for the coming year.”

—Dr. Holly Thacker, women’s health specialist at Cleveland Clinic.

“Women who have been treated for cancer often experience a loss of sexual desire as an unwelcome and surprising long-term side effect. Many survivors will greet flibanserin with enthusiasm and high hopes. But we need rigorous, independent

research to separate the hype from the benefit and to ensure that we can recommend this drug with confidence.”

—Andrea Bradford, assistant professor of gynecologic oncology and reproductive medicine at MD Anderson Cancer Center.

“To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the F.D.A. to approve useless or dangerous drugs.”

—Dr. Adriane Fugh-Berman of Georgetown University told the FDA committee in June.