TY - JOUR
T1 - Maximizing the Post-Approval Safety of Flibanserin
T2 - A Role for Regulators, Clinicians, and Patients
AU - Baksh, Sheriza N.
AU - Gellad, Walid F.
AU - Alexander, G. Caleb
N1 - Publisher Copyright:
© 2016, Springer International Publishing Switzerland.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - 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.
AB - 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.
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U2 - 10.1007/s40264-015-0389-2
DO - 10.1007/s40264-015-0389-2
M3 - Article
C2 - 26798050
AN - SCOPUS:84955296164
SN - 0114-5916
VL - 39
SP - 375
EP - 380
JO - Drug Safety
JF - Drug Safety
IS - 5
ER -