After a controversy surrounding flibanserin that has been going on since 2010, when the Food and Drug Administration (FDA) first voted against approving the drug, Sprout Pharmaceuticals has found the tide shifting in their favor. On Tuesday evening, August 18, the FDA finally approved flibanserin, which will now be marketed as Addyi. It is the first drug intended to increase a woman's sex drive by treating a condition known as Hypoactive Sexual Desire Disorder. This diagnosis refers to chronic and/or distressingly low libido in pre-menopausal women that cannot be explained by the usual factors, such as relationship troubles, stress, or medical or psychological issues.
The drug was blocked from approval twice before, because the risks that came with taking it seemed greater than the benefits it would bring. The FDA's most recent decision doesn't seem to show that these issues have been sufficiently dealt with, as it comes with a list of conditions that reflect the agency’s concerns about the side effects. These side effects include low blood pressure and fainting in patients who drink alcohol while taking the drug. In fact, doctors are required to complete a training course before being allowed to prescribe it.
"Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.
The FDA also recommends that women stop using the pill if they notice no change in their libido after eight weeks.
To read more about this recent decision and the ongoing concerns, click here.
