From The Hastings Center Report: “Addyi, a drug that made a splash when it was approved in the summer of 2015 as the first ‘female Viagra,’ is back. Its rise, fall, and rise again is an example of shrewd pharmaceutical marketing and the potential dangers it can pose to patients.”
Addyi is a SSRI which did not get FDA approval. In reviewing the data originally submitted for antidepressant approval, the drug was noted to have the typical adverse effects on sexual functioning that the other SSRIs show. When data was resubmitted for the female Viagra, there were no adverse effects on sexual functioning. One would expect that a substantial number of women prescribed this drug will show sexual dysfunction and other typical adverse SSRI effects.
Amazing – they somehow made the sexual side effects go away without altering the drug in the slightest! Could be a little “data management” going on here?
