An evaluation of the FDA adverse event reporting system and the potential for reporting bias

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Abstract
Background The FDA maintains the Adverse Event Reporting System (CAERS) database, which contains product complaint reports for foods, dietary supplements, and cosmetics. Product line perception and subsequent adverse event reporting may be impacted by negative media attention. Methods The purpose of this analysis was to use the CAERS database to analyze temporal trends in adverse event reporting before and after media coverage of alleged health effects, using WEN by Chaz Dean (WCD) cleansing conditioners as a case study. WCD cleansing conditioner adverse event reports from January 2005 to December 2018 were abstracted from the CAERS database. Zero‐inflated negative binomial regression models were used to analyze the rate of adverse events (WCD events/10,000 WCD cleansing conditioner units sold/month), adjusted for temporal trends in CAERS. Results There was a statistically significant higher rate of adverse event reporting after negative media coverage in December 2015 (IRR 16.71 [95% CI: 7.89–35.39]) when compared to the rate of adverse event reporting before December 2015. Conclusions This analysis highlights the importance of assessing potential external factors, such as negative news media coverage, that may alter reporting behaviors due to societal shifts in product‐specific risk perception. Consideration of these factors in post‐market surveillance programs would result in more comprehensive safety evaluations.

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