Bioethics Blogs

Flibanserin and Regulatory Failure

Guest Post by Adriane Fugh-Berman

On August 18th, 2015, the FDA approved flibanserin (brand name Addyi), a purported aphrodisiac that can drop blood pressure so precipitously that users sometimes pass out and require medical intervention to regain consciousness.  The labelling for flibanserin indicates that it is for:

the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

• A co-existing medical or psychiatric condition,

• Problems within the relationship, or

• The effects of a medication or other drug substance.

Focus for a moment on “Low sexual desire that causes marked distress or interpersonal difficulty”.  So a woman upset by a belittling spouse who wants sex more often than she does is eligible for a prescription drug?  It gives a whole new meaning to the term “drugs of abuse.”  Note that even if the putative patient isn’t distressed, she is still eligible for being drugged if her partner is creating interpersonal difficulty.  Here’s a thought – why not sedate him instead?

Not every partner is a jerk, and there are certainly women distressed by loss of libido, but flibanserin isn’t the answer for these women either.  As an aphrodisiac, it’s no great shakes; its predominant mechanism may simply be sedation.  Flibanserin increased “sexually satisfying events” by less than one event a month (the event, by the way, need include neither an orgasm nor a partner).

The labeling of flibanserin reveals the absurdity of this “disease” and its treatment.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.