Abstract 16027: Reporting of Neoplasms Following Angiotensin Receptor Blocker Recalls Using the FDA Adverse Event Reporting System Database

Abstract

Introduction: A worldwide recall of valsartan due to the potential carcinogen N-nitrosodimethylamine in July 2018 received extensive public attention. This was followed by more FDA recalls of other contaminated angiotensin receptor blocker (ARB) products. Our study investigated the association between the FDA recalls and ARB neoplasm adverse events (AEs) reported to the FDA Adverse Event Reporting System (FAERS). Methods: Data was retrospectively collected from the FAERS database for reports from 1/2015-12/2019. Reporting odds ratios (ROR) were estimated to detect signals for association between ARBs (valsartan, losartan, and irbesartan) and reported neoplasm AEs using negative (amoxicillin and sertraline) and positive (omeprazole and ranitidine) control exposures. Chi-square test was used to compare categorical variables. Results: A total of 2,181,524 AEs, including 19,287 neoplasm AEs were analyzed. 1-year post-recall reported neoplasm AEs were higher for valsartan than losartan ( p <0.0001) and irbesartan ( p <0.0001). Monthly ROR (95% CI) of valsartan-associated neoplasms vs. controls (ROR * : valsartan/negative exposure; ROR † : valsartan/omeprazole; ROR † : valsartan/ranitidine) showed the highest numerical signals post-recall in 7/2018 [7.64 (4.78-12.19) * ; 4.77 (3.36-6.79) † ; 4.13 (2.50-6.84) † ] and 8/2018 [(7.87 (5.19-11.94) * ; 5.65 (4.12-7.75) † ; 7.20 (4.46-11.63) † ]. In contrast, the highest post-recall cancer signals for irbesartan and losartan detected in 3/2019 (4.80 * ; 4.06 † ; 3.38 † ) and 4/2019 (3.63 * ; 3.69 † ; 2.52 † ) respectively, were lower. Conclusion: Significantly more post-recall neoplasms were reported for valsartan, with higher valsartan-associated cancer signals compared with losartan and irbesartan, even though they all contained the same carcinogenic contaminant. Extensive media coverage of the FDA valsartan recall may have alarmed patients and generated these abrupt, biologically infeasible cancer signals.