FDA reviewing new drug Flibanserin touted as ‘Women’s Viagra’

Drugs shouldn’t be approved by the Food and Drug Administration (FDA) on the back of peer pressure, and this seems to be an important issue up for debate with the new Viagra-like drug for women.

I’m talking about Flibanserin, which is undergoing FDA review as a possible treatment for low libido in women. The FDA has once again raised concern about the risk of fainting and accidental injury when the drug is combined with alcohol. Although it seems there has been statistical improvement in the number of successful sexual events (SSEs) in women taking the drug, the FDA still has to balance the benefit-risk ratio before fully approving the drug.

What appears to be driving the testing of Flibanserin is a coalition of women and couples encouraging the FDA’s approval. But the problem is it appears these groups are being funded by the drug manufacturers. I simply don’t think this is a fair way to evaluate any medication— it just creates more confusion at the end of the day.

The FDA’s review of Flibanserin, which was published on the administration’s website on Tuesday, suggested statistically significant improvement in SSEs experienced by women who used the drug, as well as reduced distress associated with low desire. The report measured an increase in the women’s desire on a monthly, not daily, basis. Numerically, however,  those differences were small.

I know that this class of drug is important because there’s been little development in drugs that address women’s sexual dysfunction— and no drugs that address this issue in women have been FDA-approved to date. However, this drug works on the brain chemistry in a similar way to selective serotonin reuptake inhibitors (SSRIs), which are part of class of antidepressants that require thorough evaluation. In fact, Flibanserin was originally developed to treat depression but proved ineffective.

It’s also important to keep in mind that the FDA has twice-rejected the approval of this drug because its risks outweighed its modest benefits, a fact that should cause everyone to take pause. Its remaining side effects include nausea, dizziness and sleepiness.  

Still, of course, the FDA has approved about two dozen similar drugs to aid male sexual dysfunction, and again none for women— making the prospect of this approval extremely promising for any woman whose personal well-being or relationship is suffering from the problem. I understand the concerns expressed by couples whose relationships are ailing, as well as activists’ concerns that a failure of this drug may stunt the development of future therapies and medications designed to increase female libido.

But when you take what appears to be conflicting interests into account, as well as potentially dangerous side effects, waiting a little longer to ensure a safe, effective drug is offered to this group of women may be well worth it. We will see how it turns out at the end of the day.

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