title: Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators, Clinicians, and Patients.
abstract: In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi®) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the unmet need of women with this disorder, extensive advocacy and politicization surrounding the product's relevance to women and sexual health, the potential for widespread off-label use, and the product's tenuous risk/benefit profile. Despite that, attention now shifts to maximizing the safe use of the product, including the optimal means to avoid numerous drug-drug interactions as well as the concomitant use of alcohol, both of which potentiate the risks of dizziness, hypotension, and syncope. Although the FDA has implemented a comprehensive Risk Evaluation and Mitigation Strategies program to maximize the product's safe use, patients, clinicians, and regulators must exhibit heightened vigilance early in the product's post-market life.
authors.affiliation: Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD, 21205, USA.|Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street W6035, Baltimore, MD, 21205, USA.
authors.forename: Sheriza N
authors.initials: SN
authors.lastname: Baksh
authors.affiliation: Division of General Internal Medicine and Center for Pharmaceutical Policy and Prescribing, University of Pittsburgh, Pittsburgh, PA, 15261, USA.|Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, 15261, USA.
authors.forename: Walid F
authors.initials: WF
authors.lastname: Gellad
authors.affiliation: Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, MD, 21205, USA. galexan9@jhmi.edu.|Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street W6035, Baltimore, MD, 21205, USA. galexan9@jhmi.edu.|Division of General Internal Medicine, Department of Medicine, Johns Hopkins Medicine, Baltimore, MD, 21205, USA. galexan9@jhmi.edu.
authors.forename: G Caleb
authors.initials: GC
authors.lastname: Alexander
mesh_terms: D017277:Drug Approval; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D056687:Off-Label Use / Q000592:standards; D004364:Pharmaceutical Preparations / Q000592:standards*; D018570:Risk Assessment; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations