FDA Approves Female Libido Boosting Drug Amid Criticism

Flibanserin, or the “pink pill” as it is sometimes referred to, is meant to treat diminished libido or hyposexual desire disorder in women. It was approved by the U.S. Food and Drug Administration (FDA) in 2015 amid much dissension, reports News & Perspective.

JAMA Internal Medicine recently published an editorial relating to Flibanserin where two doctors from the Dartmouth Institute for Health Policy and Clinical Practice are quoted calling flibanserin “a marginally effective drug for a non-life-threatening condition in the face of substantial – and unnecessary uncertainty about its dangers.”

A group of scientists claim aggressive lobbying by Sprout Pharmaceuticals, the manufacturing company behind flibanserin, for overshadowing concerns about the drug’s safety and effectiveness that lead to the eventual approval by the FDA. The editorialists added that it was unclear how much politics played a role in the FDA’s approval, but that it was “clear that the science was weak.”

Data was reviewed in studies involving 5,914 women and revealed “minimum meaningful benefit with flibanserin.” Specifically, the mean differences for change in satisfying sexual events (SSEs) from between 100 mg. flibanserin and a placebo were 0.49, or one half additional satisfying sexual event per month, News & Perspective reports. This meant on average, women had 2.5 SSEs per month before the study and flibanserin added ½ additional SSEs per month. However, adverse risks including sleepiness and dizziness increased 4-fold with the use of flibanserin.

All of the studies were randomized, double-blind, placebo-controlled trials designed to assess the effects of flibanserin in both premenopausal as well as postmenopausal women. The safety and efficacy outcomes included some undesirable side-effects. The four most common were dizziness, sleepiness, nausea and fatigue, as well as some severe and serious adverse events, according to News & Perspective.

This entry was posted in Health Concerns, Legal News, Pharmaceuticals. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.