Drug Disapproval—Flibanserin

The FDA’s approval of “Viagra for women” was all over the news this morning. Sigh. This is just wrong in so many ways. Let’s dive right in.

First, the characterization is completely off. Viagra treats a physical response, while flibanserin (brand name Addyi; and how do you say that?) treats libido, the mental aspect. The makers of Viagra and other meds for erectile dysfunction (ED) have said that if the desire’s not there, their med won’t help. And flibanserin won’t help with a woman’s physical response to sex.

Second, flibanserin is flat-out dangerous. The FDA had already denied approval twice over safety concerns, primarily nausea, dizziness, and headaches. This might not seem like much, but given the level of benefits the adverse effects were enough to kill the application twice. The makers did more studies, as asked. This time around the dangers were even more severe than first thought—but the benefits were no greater. Still, our FDA said “Yes.”

Just Say “No” to Flibanserin

Flibanserin is intended to treat a newly defined condition called Hypoactive Sexual Desire Disorder—in essence, low libido in premenopausal women. How low is “low”? Your guess is as good as mine. The makers of flibanserin define “low” as in the bottom 10% of desire. With more than 75 million women in the US between the ages of 20 and 54, 10% of that number is a nice population of new “patients.”

But what may seem low to one woman may be just fine for another. Measuring any aspect of mental or emotional functioning is a tricky business to begin with. Even in conditions such as depression and anxiety, which have been studied extensively for decades, assessment tools are notoriously imprecise. In physical conditions, part of a doctor’s job is to determine the cause behind your symptoms. Why is your blood pressure so high? What’s causing those headaches? Leaving treatment of a mental or emotional condition to your MD, though, is just asking for the symptom-treatment approach

The makers have said that they’ll require physicians to undergo training before being able to prescribe the drug, and it will be available only through “certified” pharmacists. I’ve taken some of these online training courses: two pages of text then 10 questions at the end, and voila! you’re certified. The seller has also agreed not to conduct any direct-to-consumer promotions for 18 months. Beginning in month 19, though, watch out for ads that could make your mom blush—and maybe your daughter too.

What’s Wrong About Flibanserin

As I said above, the perils of taking this drug are many and great.

  • Flibanserin tends to make you sleepy, so directions will say to take it before bedtime. There were reports in the trials of auto accidents and falls because women were getting sleepy.
  • Flibanserin makes you sleepy because it messes with your brain chemistry. Flibanserin affects receptors for serotonin and dopamine, and was first developed as an antidepressant. When researchers heard about an increase in libido from some participants, the light bulb went on.
  • Flibanserin doesn’t play nice with alcohol. So not nice, in fact, that there’s a “black-box” warning (the most serious kind) in the prescribing instructions, cautioning users not to consume alcohol while taking the drug. Umm… you want to feel like having sex more often, and no alcohol? How realistic is that for most people?
  • Flibanserin doesn’t play nice with contraceptives either. Typical hormonal contraceptives increase the frequency and severity of adverse effects, without improving the benefits. So have more sex but don’t use the Pill (or any other form of hormonal contraceptive).
  • It’s pink. Really? That’s the best marketing device you could come up with?

By the way, I don’t want to come across here as being against women’s sexuality—or even alarmed by it like some Victorian-era patriarch. I’ll go into that aspect of this drug tomorrow.

PS I came across this little tidbit about flibanserin on Friday. Take it in the spirit it’s offered.

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