Preliminary Discussion on the Risk Management of QT-prolonging Drugs Use and Its Implication

Abstract

Abstract: Objective To provide reference for the post-marketing risk management and safe use of QT-prolonging drugs in China by introducting CredibleMeds website, an important tool used by the United States to determine the clinical use of QT-prolonging drugs. Methods Literature study was used. Based on the overview of the diLQTS mechanism and factors contributing to risk of TdP, the risk categorization and risk management strategies for QT prolonging drugs were described according to the CredibleMeds website. Results With optimizing the allocation of resources, US FDA advocated the establishment of an independent QT-prolonging drugs risk management platform by an independent education and research institution and improved the utilization of safety information and drug risk management efficiency. Conclusion We should learn from the experience of drug risk management in the United States to improve the risk management capabilities of QT-prolonging drugs.

Key words: QT-prolonging drugs, torsade de pointes, risk management

CLC Number:

DING Faming, ZHANG Xinli, WANG Qiong, YIN Maoshan. Preliminary Discussion on the Risk Management of QT-prolonging Drugs Use and Its Implication[J]. Chinese Journal of Pharmacovigilance, 2018, 15(9): 545-549.

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