Studies on Requirements for the Assessment of Clinical Safety in Nonsteroidal Anti-Inflammatory Drugs

Abstract

The results of the data derived from retrospective studies on four kinds of nonsteroidal anti-inflammatory drugs (NSAIDs) were reported at the first International Conference on Harmonization (ICH-1). The frequency of adverse drug reactions (ADRs) in Japan was significantly greater than in the United States and the European Community (EC) (1). The majority of adverse reactions in postmarketing surveillance (PMS) could be detected within 12 weeks in double blind studies (2). A tentative number of patients and duration of exposure was proposed for approval. In order to confirm this tentative proposal, an additional retrospective study on another NSAID, Drug E, was performed with traditional retrospective PMS and new prospective PMS in which enrolled patients were registered at the start of surveillance. The results of this study supported the ICH-1 tentative proposal. The new prospective PMS provided higher quality information on rare uncommon ADRs than traditional retrospective PMS.

Keywords

Adverse drug reactions Retrospective study Prospective PMS

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References

Strom

. The promise of pharmacoepidemiology. Ann Rev Pharmacol Toxicol. 1987;27:71–86.

Homma

Requirements for the assessment of clinical safety. Regulatory Perspectives. In D'Arcy

Harron

DWG

, ed. Proceedings of the first international conference on harmonization. Belfast, Ireland: The Queen's University of Belfast; 1992.