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Addyi Approved with Boxed Warning

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Tyler Goodwin2 years ago

Last Tuesday, the U.S. Food and Drug Administration (FDA) approved the first drug to treat low sexual desire in women; however, and advisory panel will require the drug to carry a “boxed warning” for certain side effects.

Addyi's Rocky Road to Approval

The pink pill, branded as Addij, was developed by Sprout Pharmaceuticals and will only be sold through professional healthcare trained individuals and pharmacies because of its high-risk potential.  

Addyi was made for premenopausal women who are under stress because of a lack of sexual desire otherwise known as hypoactive sexaul desire disorder, or HSDD. The pink pill should be taken daily.

However, Public Citizen, a watchdog group, testified against the Addyi before its release, claiming the drug would more than likely be pulled from the market because of “serious dangers to women with little benefit.”

Addyi had been rejected twice by the FDA prior to its recent approval in which an advisory panel concluded that users of the pill should be fully aware of the risks.

How Does Addyi Work?

Where Viagra affects blood flow to the genitals to enhance male performance, Addyi is designed to activate sexual impulses in the brain; similar to selective serotonin, reuptake inhibitors, or SSRI’s, that include antidepressants.

In a clinical study, the women who took Addyi had an increase of about one sexually satisfying event per month than those who took placebo. Although it is an increase, it is a small increase. 

Potential Side Effects of Addyi

Addyi’s packaging will include a “boxed warning” addressing a risk of severe hypotension and syncope when taken with alcohol.

Further, the FDA warns drug should not be used by people with liver impairment or those who are currently taking CYP3A4 inhibitors.


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