Tuesday, 1 March 2016

Female Viagra safety efficacy questioned in new study

The drug flibanserin, approved last year by the US Food and Drug Administration to boost sexual desire in women who are entering the menopause, has limited benefits and produces negative effects.

Hypoactive sexual desire disorder (HSDD), also known as female sexual interest/arousal disorder, affects 10-40% of women.

HSDD is defined as "persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity," accompanied by "marked distress and interpersonal difficulty" that does not stem from a non-sexual mental disorder, medication, relationship stress or another medical condition.

Flibanserin - dubbed the "female Viagra" - was approved last year by the Food and Drug Administration (FDA) in a high-profile decision that attracted attention from the public and health professionals alike.

Added to safety issues were concerns about the medicalization of women's sexuality. It was unclear whether the benefits were worth the risks, and questions were raised about the influence of the pharmaceutical lobby on FDA decisions.

Sprout Pharmaceuticals purchased the rights to flibanserin after the FDA originally rejected it. They aroused support, including helping to create and fund the "Even the Score" advocacy campaign. The campaign claimed that sexism had motivated the rejection, rather than scientific evidence.

Within 48 hours of FDA approval, Valeant Pharmaceuticals, of which Sprout was a division, purchased the rights to flibanserin for about $1 billion in cash.

Dr. Loes Jaspers, of the Erasmus University Medical Center in Rotterdam, the Netherlands, and coauthors carried out a meta-analysis of the records of clinical trials for 5,914 women.

Resource: - http://www.medicalnewstoday.com/articles/307186.php