“Pink Viagra” (Flibanserin): lots of risks and almost no benefit

June 2010

The FDA Reproductive Health Advisory Committee met on June 18, 2010 to discuss approval of Flibanserin for “hypoactive sexual desire disorder,” or low sexual desire. This drug is specifically meant to treat this condition in women.

NRC president Diana Zuckerman recommended against approval of Flibanserin (see her comments in Rodale News) and the FDA advisory committee agreed, voting against approval of Flibanserin.

Dr. Zuckerman’s concerns are:

  • It doesn’t work.  Women on placebo improved almost exactly as much as those on the drug in the U.S. study – and the drug produced no behavioral change compared to placebo in the European trials.  At most, Flibanserin might add 3 satisfying sexual experiences PER YEAR for women taking this drug EVERYDAY for a year, compared to placebo.
  • Flibanserin affects seratonin, like SSRI antidepressants, and we know those drugs have substantial risks. The drug is intended for women of childbearing age who already are cautioned by the FDA to avoid seratonergic drugs like this one during pregnancy and while breastfeeding. The American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice explicitly recommends that paroxetine (Paxil, an SSRI) be avoided by pregnant women and women planning to become pregnant. We expect a similar risk for this drug but it hasn’t been adequately studied.
  • Women taking Flibanserin withdrew early from the U.S. trial because of side effects- many more than among women taking placebo. This needs further evaluation.

Flibanserin is a drug that affects the brain and must be taken everyday for weeks in order to get any benefit at all.  It must be taken continuously (daily and indefinitely) and if a woman stops taking it, she can experience problems.  In contrast, Viagra affects blood flow-for a few hours on the day that it is taken.  In addition, “hypoactive sexual desire disorder” (HSDD) is a controversial diagnosis for women’s lack of sexual desire and it may be reclassified in the DSM-V.  It is not clear that it is caused by physiological problems.  It may be caused by emotional or other issues that can’t be solved by a pill.  There will be enormous advertising and payments to doctors to promote this drug and to convince a large portion of the female public that they need this drug.  This is already underway.  Most women who use it won’t benefit at all, and some will be harmed.

The data suggest that giving a vitamin and calling it “pink viagra” would help women as much as these pills and would not have the same risks.  The greatest benefit of these drugs would be to the company making money from these pills, not the women taking them.

There is no doubt that some women lose sexual desire, especially as they age.  It would be great if there was a safe and effective drug to help them, but this drug is not it.