The association between colorectal cancer drugs and heart failure: a real-world pharmacovigilance study of the FAERS database.

[BACKGROUND] Colorectal cancer (CRC) is a prevalent cancer. Heart failure (HF) is a well-recognized adverse reaction to CRC drugs.

[METHODS] This study interrogated the FDA Adverse Event Reporting System (FAERS) database from to comprehensively investigate the risk of HF associated with CRC drugs.

[RESULTS] The annual number of reports peaked in 2017 and has shown a consistent upward trend in the most recent period. The physicians constituted the most substantial group. Male patients contributed the most reports. The 65 to 85 age group constituted the majority of the reports. It is notable that the United States was the largest contributor of reports. The majority of HF reports occurred within 0 to 30 days after drug administration. These reports were frequently associated with serious outcomes. There were 20 drugs that met the threshold of not less than 3 reports, including bevacizumab, oxaliplatin, fluorouracil, capecitabine, and cetuximab. The Reporting Odds Ratio (ROR) method, the Proportional Reporting Ratio (PRR) method, the Bayesian Confidence Propagation Neural Network (BCPNN) method, and the Multi-item Gamma Poisson Shrinker (MGPS) method were utilized. Fluorouracil, aflibercept, ramucirumab, atezolizumab, trametinib, and ipilimumab met the criteria of more than 3 reports and a positive ROR signal. A strong association between HF risk and the utilization of aflibercept or ramucirumab in CRC was found.

[CONCLUSION] The study offers the first real-world pharmacovigilance analysis of HF risks associated with CRC drugs using the FAERS database. It contributed critical evidence to inform the safe clinical use of CRC drugs.