Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America

Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (12): 714-718.

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Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America

XU Rong-qin, XU Mei-ting ,YANG Yue^*

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2013-03-05 Revised:2016-03-09 Online:2013-12-08 Published:2016-03-09

Abstract

Abstract: Objective To analyze post -marketing risk management of rosiglitazone in America, in order to provide references for risk management of post -marketing drugs in China. Methods By searching medical literature from the FDA and CFDA website, and collecting rosiglitazone related information, it introduced the risk evaluation and mitigation strategy(REMS) on rosiglitazone in America. It analyzed post -marketing supervision of rosiglitazone in China and compared the risk intervention measures of China with America's. Results and Conclusion The American rosiglitazone REMS is an important measure in post-marketing supervision and it strictly limited the use of rosiglitazone. It has significant meaning to guide our drugs post-marketing risk management.

Key words: rosiglitazone, risk evaluation and mitigation strategy, risk benefit

CLC Number:

R951

XU Rong-qin, XU Mei-ting ,YANG Yue. Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America [J]. Chinese Journal of Pharmacovigilance, 2013, 10(12): 714-718.

References

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Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America

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