I am dismayed at the FDA’s approval of Addyi (flibanserin) the first drug to treat low sex desire in pre-menopausal women.
To call this new drug the “Pink Viagra” is not medically accurate.
Unlike Viagra, which works by increasing blood flow to a man’s penis, Addyi works on the central nervous system and affects three brain neurotransmitters: increasing dopamine and norepinephrine (both responsible for sexual excitement) while decreasing serotonin (responsible for sexual satiety/inhibition), according to FDA briefing documents.
Addyi is a brain-altering drug, which has potentially serious side effects on women who take birth control, antidepressants, migraine medications or drink alcohol, according to FDA briefing documents.
I am also concerned that Addyi will be used off-label for people who were not tested in the clinical trials, particularly post-menopausal women, due to unknown side effects. This also was a serious consideration for an FDA Advisory Committee panel who met in June 2015 to evaluate the clinical trials for this drug.
So let’s not perpetuate this myth that there is some kind of gender inequality because there are approved drugs that help men with sexual functionality and none for women. Sexual response in a woman cannot be treated in the same way as a man’s which involves the mechanics of erectile dysfunction. Sexual desire in a women is more complex.
To draw a parallel by calling this new drug “Pink Viagra” is just marketing hype, which was part of a targeted and calculated PR campaign, developed by a group called Even the Score.
Why? This was the third time the FDA reviewed Addyi, because the drug failed to meet the FDA’s standard for safety and efficacy twice, in 2010 and 2013, due to side effects.