Abstract
Background
The Weber effect states that adverse event (AE) reporting tends to increase in the first 2 years after a new drug is placed onto the market, peaks at the end of the second year, and then declines. However, since the Weber effect was originally described, there has been improvement in the communication of safety information and new policies regarding the reporting of AEs by healthcare professionals and consumers, prompting reassessment of the existence of the Weber effect in the current AE reporting scenario.
Objectives
To determine the AE reporting patterns for new molecular entity (NME) drugs and biologics approved in 2006 and to examine these patterns for the existence of the Weber effect.
Methods
Publicly available FDA Adverse Event Reporting System data were used to assess the AE reporting patterns for a 5-year period from the drug’s approval date. The total number of annual reports from all sources, based on the report date, was plotted against time (in years).
Results
In the period from 2006 to 2011, a total of 91,187 AE reports were submitted for 19 NMEs approved in 2006. The highest number of AE reports were submitted for varenicline tartrate (N = 47,158) and the lowest number for anidulafungin (N = 161). Anidulafungin was reported to have the highest proportion of death reports (36 %) and varenicline tartrate the lowest proportion (1.7 %). The classic Weber pattern was not observed for any of the 19 NMEs approved in 2006. While there was no one predominant pattern of AE report volume, we grouped the drugs into four general categories; the majority of drugs had either a continued increase in reports (Category A 31.6 %) or an N-pattern with reporting reaching an initial peak in year 2 or 3, declining and then beginning to climb again (Category B 42.1 %).
Conclusions and relevance
There have been numerous changes in AE reporting, particularly a huge increase in overall annual report volume, since the Weber effect was first reported. Our results suggest that a Weber-type reporting pattern should not be assumed in the design or interpretation of analyses based on AE reports.
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Author’s contributions
Pankdeep Chhabra and Xing Chen: study design, data analysis, interpretation of data, and manuscript preparation; they had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Sheila Weiss: study design, interpretation of data, and manuscript preparation. Qscan-FDA was provided for this research through an in-kind donation from Druglogic, Inc. to the Center for Drug Safety, University of Maryland School of Pharmacy.
Conflict of interest disclosure
Pankdeep Chhabra: Now an employee of Sanofi Pasteur (a vaccine company). However, the employment began after the completion of the first submission of this manuscript.
Xing Chen: No conflict of interest disclosure
Sheila Weiss: Consulted for directly, served on the advisory board, served on a grant or contract (as a principal investigator or as an investigator), consulted with their legal representatives as an expert, and/or worked as an employee in the last 3 years: University of Maryland, Johns Hopkins School of Public Health, Georgetown University, National Cancer Institute, DrugLogic Inc., United Healthcare/Optum, Pfizer, Bayer, Esai, Novartis, Amgen, Biogen Idec, and Roche.
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No funding or support was available for this study.
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Chhabra, P., Chen, X. & Weiss, S.R. Adverse Event Reporting Patterns of Newly Approved Drugs in the USA in 2006: An Analysis of FDA Adverse Event Reporting System Data. Drug Saf 36, 1117–1123 (2013). https://doi.org/10.1007/s40264-013-0115-x
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DOI: https://doi.org/10.1007/s40264-013-0115-x