Key result
Valsartan is linked to ~77% more reported neoplasm adverse events than irbesartan, likely driven by media coverage.
Why the study?
Following extensive media attention on FDA recalls of ARB products contaminated with N-nitrosodimethylamine, this study investigated the association between the recalls and ARB neoplasm adverse events reported to the FDA adverse event reporting system.
Does the FDA recall of ARBs increase the reporting of neoplasm adverse events in the FDA adverse event reporting system?
Population
2 181 524 AEs, including 10 461 nonmetastatic neoplasm AEs in the FDA database
Comparison
ARBs (valsartan, irbesartan, losartan) vs negative and positive control exposures
Design
Retrospective cross-sectional study
Authors
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Media coverage may inflate neoplasm signals in FAERS after ARB recalls; challenges causal inferences from unadjusted spontaneous reports.
Cross-Sectional (n=2,181,524)
Does the FDA recall of ARBs increase the reporting of neoplasm adverse events in the FDA adverse event reporting system?
Odds Ratio: 1.77 (95% CI 1.47–2.13)
p-value: p=<0.0001
Extensive media coverage of the FDA valsartan recall likely generated abrupt, biologically infeasible cancer signals in the FDA adverse event reporting system, highlighting the impact of media on adverse event reporting.
Sedgh et al. (2021) conducted a cross-sectional in Neoplasm adverse events (n=2,181,524). Valsartan vs. Irbesartan, losartan, and control exposures was evaluated on Reported neoplasm adverse events 1-year postrecall (OR 1.77, 95% CI 1.47-2.13, p=<0.0001). One-year postrecall reported neoplasm adverse events were significantly higher for valsartan than irbesartan (OR 1.77; 95% CI 1.47-2.13; P<0.0001), likely driven by media coverage.