Temporal patterns of NSAID spontaneous adverse event reports: the Weber effect revisited.

作者: Eric J. Wallenstein , Daniel Fife

DOI: 10.2165/00002018-200124030-00006

关键词: Reporting rateEmergency medicinePharmacovigilanceSurgeryNabumetonaFood and drug administrationNonsteroidalFlurbiprofeneAdverse effectOxaprozineMedicine

摘要: Objectives: Determine whether recent US adverse event reports for several nonsteroidal anti-inflammatory drugs (NSAIDs) conform to the temporal pattern observed by Dr JCP Weber in UK early 1980s, i.e. a rising count first few years after launch presumably reflecting increased exposure, followed decline, decreased enthusiasm reporting as events become well known. Study Setting: report data available from Food and Drug Administration, reformatted commercial vendor. Methods: For 5 NSAIDs launched between 1987 1993 that had suitable this study, we tabulated year number of rate (number per 1000 prescriptions). Results: The 3 showed approximating described Weber. other 2 patterns markedly different 4 NSAIDs, rates did not decline consistently with time launch. Discussion: are more complex than those Weber’s classic report. does reliably rise then fall decrease

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