Reviewing Drug Safety Risk Management Based on Drug Withdrawl Experiences in USA.

Abstract

Abstract: Objective To analyze causes of drug withdrawls in USA and to emphasize that risk management of post-marketing drugs is very important to the public health. Methodse Medical literatures and US FDA website were searched and analyzed regarding information on drugs that have been withdrawn or removed from the market in USA. Results A total of 72 products were withdrawn or removed from USA during 1964 and 2009. The common safety causes of withdrawal include cardiovascular events, carcinogenic risk, liver toxicity, blood disorders, skin disorders, neurologic/mental disorders, renal toxicity, and so on. Conclusion Risk management should be considered throughout a drug’s lifecycle from development to post-market usage. Risk management of post-marketing drugs is particularly important. Drug withdrawal is the last approach for post-marketing safety risk management.

Key words: post-marketing drug, drug safety, risk management, withdrawal, FDA

CLC Number:

R954

GUO Xiao-xin, DU Xiao-xi, XUE Song-lin. Reviewing Drug Safety Risk Management Based on Drug Withdrawl Experiences in USA.[J]. Chinese Journal of Pharmacovigilance, 2011, 8(4): 212-215.

References

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