In August 2015, despite safety concerns, the US Food and Drug Administration (FDA) approved Addyi (flibanserin) as a medical treatment for hypoactive sexual desire disorder (HSDD; low libido) in premenopausal women. A large, new study has found that, in addition to safety concerns, fibanserin use has only a miniscule effect on HSDD and produced a significant increase in the risk of dizziness, somnolence (drowsiness), nausea, and fatigue. The findings were published online on February 29 in the journal JAMA Internal Medicine by Dutch researchers
The study authors note that HSDD has a prevalence ranging from 10% to 40%. The condition is defined as “persistently or recurrently deficient (or absent) sexual fantasies and desire for sexual activity” accompanied by “marked distress and interpersonal difficulty” that is not accounted for by a nonsexual mental disorder, medication, severe relationship stress, or a general medical condition. They explained that the approval of flibanserin sparked controversy among health institutions and stakeholders in the product. Therefore, in view of this controversy, they conducted a systematic review and a meta-analysis to evaluate its effectiveness and safety for the treatment of HSDD in women. (A meta-analysis is a compilation of data from a number of studies to clarify a point.)
A systematic review and meta-analysis of five published and three unpublished clinical trials found that treatment with flibanserin resulted in one-half additional satisfying sexual event per month while significantly increasing the risk of dizziness, somnolence, nausea, and fatigue. They concluded that before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities (other medical problems), medication use, and surgical menopause.
The researchers are affiliated with: Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Family Medicine, Vrije Universiteit Brussel, Brussels, Belgium; Medical Library, Erasmus University Medical Center, Rotterdam, the Netherlands ; Department of Sexology, Groene Hart Hospital, Gouda, the Netherlands; and Department of Sexology and Psychosomatic Obstetrics and Gynecology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Take home message:
Many factors can affect libido, including, fatigue, stress, and marital discord. Rather than taking a pill that has both minimal effectiveness and significant side-effects, search for other factors affecting your libido. Counseling or a discussion with a healthcare provider may be helpful.