The Dangerous Side Effects of the Viagra for Women Pill, Flibanserin

This is the day many women have been waiting patiently for. The Food and Drug Administration has finally approved a drug that's designed to help women enjoy sex more and increase their libido.

A drug called flibanserin made by Sprout Pharmaceuticals for the treatment of premenopausal women with hypoactive sexual desire disorder, or loss of sex drive. 

The drug will be sold under the brand name  Addyi, will be available in October. So why isn't everyone celebrating? Well, there are several problems with this drug. 

The little pink pill is not very effective, and the FDA rejected the drug once in 2010 and again in 2014, because of serious and dangerous side effects. But after aggressive and powerful marketing campaigns by the flibanserin's manufacturer (Sprout), and women's' advocacy organizations, the drug was finally approved. 

So here are some reasons to be concerned about "Viagra for women."

The FDA research into flibanserin revealed that between 8 and 13 percent of women saw some improvement over the placebo.  The women in the study averaged 0.5 more "sexually satisfying events" per month. While it is an increase over the placebo, it is a very small and negligible amount.

 According to  Dr. Adriane Fugh-Berman — the director of the PharmedOut project at Georgetown University who researched the marketing campaign of flibanserin — weighed in with her opinion, "a mediocre aphrodisiac with scary side effects."

While all drugs have side effects. All patients should discuss treatments with their physician to determine whether the risk of taking the drug outweighs the benefits. This is the case with all medications and medical treatments.  Since flibanserin doesn't appear to have greatly increased women's' sex drives in all the clinical studies, it would seem that the risks may greatly outweigh the benefits because there are some serious side effects with this drug.  

The most serious side effect of flibanserin is hypotension or very low blood pressure.  When a person has hypotension, they can become dizzy and pass out. If the medication is taken with alcohol or in combination with hormonal contraceptives the risk of this side effect can increase. One in five women who took the drug during the clinical study reported having adverse effects. The side effects included dizziness, fainting, and drowsiness. Hypotension is a less common effect.


The FDA's suggestion for these side effects is that woman take the medication before bed, and only health care professionals who have been trained about the side effects of the medication are permitted to prescribe the drug.  Physicians and Nurse Practitioners will need to assess patients for their ability to abstain from alcohol before prescribing. 

Another problem is that there will always be patients who are non-compliant with the way the medication should be taken, and some will take the medication in the morning or when drinking which can lead to these dangerous side effects.

All of the clinical trials on the drug were conducted on healthy women who weren't on any medications for anxiety or insomnia. So we really don't know what the long term effects of this drug could be. 

 

Since the drug was rejected twice because of its serious side effects the drug company launched a major marketing campaign to "Even the Score." The objective here was to allow women the same opportunities as men to treat their sexual dysfunction. It was a powerful campaign because the evidence that caused the rejections in the past had not changed, but since there are 26 FDA-approved drugs to treat sexual disorders in males, none were available for women. 

But the truth is that this "Even the Score" campaign doesn't make sense because there are no drugs to treat decreased sex drive in males either. Yes, there are 26 drugs available to males, but they are not for this disorder.  Medications available to men are used to treat mechanical problems, like erectile dysfunction or low testosterone- which is not the same goal of this flibanserin. 

The campaign also told the FDA that they were sexist for not fast-tracking the drug for approval like they did with Viagra.  "Why do we fast track the approval of drugs like Viagra (1998) for men? Why do we accept fewer patients in trials for male drugs than we've seen for some for women?" It reads on the campaign website. 


Others have accused the pharmaceutical industry of inventing the medical condition(hypoactive sexual desire disorder) that this medication was developed to treat, for their own personal financial gain.

So is a drug with so many side effects better than no drug at all?