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Is the New "Pink Viagra" Safe?

The FDA just approved the first prescription drug to target low female libido, after failing to pass twice before.  How safe is flibanserin (referred to as the "Pink Viagra"), and how does it really work?

By
Sanaz Majd, MD,
August 27, 2015
Episode #195

Page 1 of 2

As a doctor, one of the challenges of practicing medicine includes those ailments that I simply cannot fix or even help alleviate.  Female libido and low sexual desire is one of those very pervasive and potentially frustrating issues that has remained medically untreatable.  

But now, finally, a seemingly major milestone has been achieved in female sexual health in the recent past: the FDA just approved the first prescription drug to boost female libido this month. But the FDA also rejected the drug twice, in 2010 and 2013, due to concerns with patient safety outweighing its potential benefits in the past. And it has now only been FDA approved with stringent safety restrictions. 

Why is that? How safe is it? How does it work? Let’s find out.

What Is "Pink Viagra"?

They may be calling it the “Female Viagra,” or “Pink Viagra,” but flibanserin (otherwise known as brand "Addyi") is nothing like Viagra. It actually works on the chemical in the brain called serotonin. By changing the serotonin activity in the brain, it reportedly helps to boost sexual desire … but not immediately. You can't simply take it “as needed” an hour before sexual activity like with Viagra; similar to antidepressants that work on serotonin receptors, which take weeks to take effect, this drug also takes weeks to months of daily use for someone to notice a change.

And the reported change has been said to be merely a mild one, with only an increase of one sexual event per month. Not very life-changing for most.

The drug manufacturer has also reportedly created a campaign to pressure FDA approval for the third time, gaining audiences this time by claiming FDA gender bias in failing to treat female conditions like sexual dysfunction. Meanwhile, the company also yearned to reach the same immense monetary success that Viagra yielded. It's important to note, however, that male erectile dysfunction is a much more targeted and specific medical condition to treat by simply increasing penile blood flow. Viagra is not effective in men with low libido, only those with a problem with maintaining erections.  

But low libido in women is a much more complex and less definable issue. Female sexual dysfunction is often due to numerous factors that all contribute to the process, and therefore less specific and more challenging to target. These factors can include:

  • depression and anxiety
  • life stressors
  • interpersonal conflict between the couple
  • medication side effects
  • age
  • religious concerns
  • personal health
  • privacy issues
  • personal body image
  • substance and alcohol abuse
  • hormonal influences

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