New study claims female Viagra marginally effective and has multiple side effects

The little pink pill has not yet made it to the same league as its predecessor, the little blue one. A recent study published in the Jama Internal Medicine states that while the newly-launched female Viagra pill, Addyi, does affect women's libido, it does so only modestly. Additionally, the research indicated that the drug had a number of side effects including dizziness, somnolence, nausea and fatigue.

The research, Efficacy And Safety Of Flibanserin For The Treatment Of Hypoactive Sexual Desire Disorder In Women, which was published on 29 February, studied the effects of the drug. Popularly known as the female Viagra, the study was conducted on a group of 5,914 women from different age groups and backgrounds, who suffered from hypoactive sexual desire disorder (HSDD).

"The findings indicate that flibanserin results, on average, in a monthly increase in satisfaction of one half of one sexual event, but that it significantly increases dizziness, sleepiness, nausea and fatigue among women using it. The overall impression of the women surveyed was that the drug led to either minimal or no improvement," the study stated.

The drug had been rejected twice by the US Food and Drug Administration as a solution for premenopausal women with HSDD. Drug company Valeant picked up flibanserin and in 2015 it finally received approval making it the first-of-its-kind drug to treat low sexual desire in women.

This recent study's results are very similar to the original findings put forward to the FDA, but show even lower positive effects of the drug while the possibility of suffering from adverse effects (AEs) are higher. "The most common reported AEs were of mild and moderate intensity, and serious AEs were equally low in flibanserin and placebo users. This reflects positively on flibanserin's safety, but the conclusion that flibanserin is safe is premature," the research mentioned.

The systematic review and meta-analysis is made up of five published and three unpublished studies conducted in the US, Canada, with one conducted across 13 European countries.

Dr Steven Woloshin and Dr Lisa M Schwartz, of the Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, NH, as part of a commentary linked with the study, stated, "The flibanserin saga is unsatisfying. The FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial, and unnecessary, uncertainty about its dangers. Women with distressing sexual desire problems need good treatments. We all need a drug approval process that delivers good decisions based on adequate evidence."

Valeant however, were quick to dismiss the findings. In a statement, Dr Tage Ramakrishna, the chief medical officer at Valeant said that aside from confirming previously published findings, the new study "provided little additional context".

He went on to criticise the manner in which the research was conducted – combining data from a number of different studies – and said that it carried "less statistical weight".