Bioethics News

The female Viagra, Flibanserin. Authorised by the FDA in a controversial decision

Female Viagra.”Hypoactive sexual desire disorder” to which the indication for the new drug refers, is very controversial”.

On 4th June this year, a United States Food and Drug Administration (FDA) advisory committee, responsible for the regulation and authorisation of drugs, recommended the approval of flibanserin as a novel medication for the treatment of pre-menopausal women with “hypoactive sexual desire disorder”. The FDA awarded it marketing approval on 19th August.

Its indication suggests — although it is not the same substance — that it is equivalent to the female version of the male “Viagra”, with subtle differences. Unlike Viagra, which is only taken before sex in the case of erectile dysfunction, the new drug should be taken regularly on a daily basis at bedtime in order to minimise the side effects, regardless of whether or not the person intends having sex. This presents a new scenario, given the continuity of treatment and the likely side effects that could appear with time.
This recommendation has not been free of controversy. The FDA had refused to approve the medication with the designated indication on three previous occasions, as it considered that the risk/benefit balance did not justify its authorisation.

A new drug?

Flibanserin is not new. It is actually a molecule that was initially promoted as an antidepressant, but clinical trials were unsuccessful. At the beginning of this century, the pharmaceutical company responsible for this substance was Boehringer Ingelheim. After its failure, it was decided to test its efficacy as a treatment for the disorder known as “hypoactive sexual desire disorder”, which was said to affect 10% of women.

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.