Story highlights The Food and Drug Administration approves the first drug for female sexual desire with caution

Flibanserin, which some call "female Viagra," is for treatment of hypoactive sexual desire disorder

The drug failed two times before it was recommended for approval in June

(CNN) Women who have lost their sex drive will have a little pink pill to help them come October. On Tuesday, the U.S. Food and Drug Administration approved flibanserin, which will be sold as Addyi, for the treatment of sexual dysfunction in premenopausal women.

This is the first FDA approved treatment for sexual desire in men or women.

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"Today's approval provides women distressed by their low sexual desire with an approved treatment option," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said in a statement announcing the approval. "The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction."

The approval is not without warnings. In fact, the agency approved the drug with a risk evaluation and mitigation strategy, or REMS, to ensure safety. Of greatest concern, an increased risk of severe low blood pressure, so low it can cause a temporary loss of consciousness. This is more of a concern in patients who drink alcohol while taking the drug. As required by REMS, health care providers who prescribe the medication and pharmacies that dispense it are required to first complete a training program to become certified. They will be required to warn patients of the risks of consuming alcohol while taking Addyi and the importance of not doing so.

In addition, the agency is requiring a "boxed warning" to notify patients who drink alcohol, have liver problems or those who take medications called CYP3A4 inhibitors (which interfere with the breakdown of the medication in the body) not to take Addyi.

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