News Brief for November 2015

FDA Approves Drug for Female Sexual Desire Disorder; Public Citizen Warns of Dangers

The Food and Drug Administration (FDA) in August approved flibanserin (ADDYI), the first drug to treat hypoactive sexual desire disorder in premenopausal women.[1] In response, Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, issued a press statement warning of serious dangers with this drug and predicting that it will be removed from the market within a few years.[2] According to Wolfe’s statement, the FDA's own analysis of the drug found it to be minimally effective and warned of side effects such as abnormally low blood pressure and fainting, which can result in "serious, irreversible or life-threatening injuries." In combination with alcohol, flibanserin is even more dangerous, and the FDA noted the difficulty in preventing women from drinking alcohol while taking the drug. Only health professionals and pharmacists who meet certain certification requirements will be allowed to prescribe and dispense flibanserin.[3] Public Citizen’s Health Research Group designates flibanserin as Do Not Use.

References

[1] Food and Drug Administration. FDA approves first treatment for sexual desire disorder. August 18, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm. Accessed August 28, 2015.

[2] Public Citizen. FDA’s big mistake: Expect flibanserin to be pulled from the market in a few years. August 19, 2015. http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5620. Accessed August 28, 2015.

[3] Ibid.