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最大化氟班色林批准后的安全性:监管机构、临床医生和患者的作用

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

作者信息

Baksh Sheriza N, Gellad Walid F, Alexander G Caleb

机构信息

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.

出版信息

Drug Saf. 2016 May;39(5):375-80. doi: 10.1007/s40264-015-0389-2.

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.

摘要

2015年8月,美国食品药品监督管理局(FDA)做出了一项有争议的决定,批准氟立班丝氨(Addyi®)用于治疗性欲减退障碍的女性。有诸多因素导致了对FDA这一决定的分歧,包括该产品此前两次未通过FDA审评、患有该疾病的女性的需求未得到满足、围绕该产品与女性及性健康相关性的广泛宣传和政治化、广泛的超说明书用药可能性以及该产品脆弱的风险/获益状况。尽管如此,现在注意力转向了使该产品的安全使用最大化,包括避免众多药物相互作用以及同时饮酒的最佳方法,这两者都会增加头晕、低血压和晕厥的风险。虽然FDA已实施了一项全面的风险评估和缓解策略计划以最大化该产品的安全使用,但患者、临床医生和监管机构在该产品上市后的早期阶段必须保持更高的警惕性。

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