Steve Heronemus

What Will the FDA Approve, Part, 2

August 18, 2015 the Food and Drug Association approved Addyi, the “female Viagra” said to increase desire for sex among premenopausal women.

When available in October, the Sprout Pharmaceuticals product will carry a black box warning, the strongest caution the FDA issues for side effects. Addyi can cause life-threatening complications for women with liver weakness, low blood pressure, dizziness, and fainting.

With all these problems, one would be excused for thinking Addyi must be quite effective but it isn’t. Taken every day, Addyi might lead to one extra satisfying sexual encounter a month.

Now I’m certainly not opposed to healthy sex lives, but if Addyi is neither particularly effective nor safe, why did the FDA approve it? After all, ALS drugs by Genervon and Neuraltus, among others, can’t get approval even with better safety profiles and good potential to save lives. The answer is that the FDA bowed to lobbying orchestrated by Sprout Pharmaceuticals, backed by investors lured by a huge market potential. In today’s FDA money counts more than lives, proving once more it is a political organization and not one dedicated to protecting life.