Maximizing the Post-Approval Safety of Flibanserin: A Role for Regulators, Clinicians, and Patients

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 faile...

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Bibliographic Details
Published in:Drug safety 2016-05, Vol.39 (5), p.375-380
Main Authors: Baksh, Sheriza N., Gellad, Walid F., Alexander, G. Caleb
Format: Article
Language:English
Subjects:
Alcohol
Clinical medicine
Current Opinion
Drug dosages
Drug Safety and Pharmacovigilance
FDA approval
Funding
Medicine
Medicine & Public Health
Nervous system
Pharmaceutical industry
Pharmacists
Pharmacology/Toxicology
Product safety
Serotonin
Studies
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Summary: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.
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-015-0389-2