FDA’s Big Mistake: Expect Flibanserin to Be Pulled From the Market in a Few Years
Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group
The U.S. Food and Drug Administration’s (FDA’s) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency’s briefing package to the advisory committees that met on June 4 to review the drug.
It would not be surprising that after enough women have been seriously harmed by the “irreversible, or life threatening injuries” about which the FDA is concerned, flibanserin will have to be taken off the market. It is unconscionable that the FDA does not have the courage to prevent such damage from a drug with such a high ratio of risks to benefits.
The FDA’s analysis showed that women using the drug had an average of only half to one more “satisfying sexual encounter” every month compared to those using a placebo.
Meanwhile, the FDA’s list of serious risks includes abnormally low blood pressure and fainting. The agency noted that these could be experienced when flibanserin is taken alone or with alcohol, and that these side effects “can result in serious, irreversible, or life threatening injuries.”
The agency also noted that a study showed taking the drug with alcohol consumed over 10 minutes led to drowsiness, low blood pressure when standing up, and fainting. Although the study subjects were predominantly male (23 of 25 subjects), the FDA stated that “[t]he effect of the combination of flibanserin and ethanol may be more pronounced in females.”
The FDA noted the difficulty of preventing alcohol use in women using the drug, saying that limits on such prevention would exist even with the implementation of a type of risk management plan intended to ensure that the benefits of prescription drugs outweigh their risks.
Unfortunately, we haven’t heard the last of this drug. Expect future news to include stories of women who are harmed needlessly by flibanserin and the eventual agency call for the manufacturer to pull it from pharmacy shelves.
August 28, 2015 @ 9:36 pm
Infuriating. I’ll warn everyone I possibly can away from this stuff.
August 29, 2015 @ 9:57 am
Oh FDA, what has happened to you? Teddy Roosevelt started you for a reason! Please reread Upton Sinclair’s THE JUNGLE. Please FDA, rethink the following issues:
The 23 out of 25 persons test subjects were men…. testing for a drug for women? Say What? Didn’t we all learn that men and women have different reactions to things… you know, like heart attacks? How many women have died because they didn’t show men’s symptons for heart attacks? Aren’t gender reactions and responses to medical events important?
This drug can cause fainting? Wow, I see car accidents and deaths in your future Flibanserin!
Don’t use with alcohol? Maybe a date rape drug too? So, FDA , when a drug cause more problems than what it is supposed to fix, don’t you think this is a problem?
FDA: here are some things I have learned lately:
Bayer once invented, and widely sold, a drug that made people happy and heroic….oh wait—HEROIN…..yeah that was a disaster! You see, when you sell something before it’s been truly tested, it can be life changing in a NEGATIVE way!
Vioxx——in use for SEVEN years and KILLING people for SEVEN years! So FDA, how did that happen?
For anagram lovers, the word BAN is within Flibanserin’s name… maybe that’s a clue?
Please FDA, Teddy started you for such good reasons:
1) people are not lab rats
2)PEOPLE are more important than profits!
FDA, please, can we return to the 20th century when HUMANITY was your most important product!~
August 29, 2015 @ 4:03 pm
Great statement!!!!!! Totally agree!!!!! Woman drug with 23 of 25 men tested…. Insane!!!!!!! Thanks for your speaking out!!!!!!!!!