Antineoplastic agents associated with neutropenic enterocolitis in patients with malignancy: A quantitative safety signal analysis

Background: The use of certain chemotherapy agents is associated with the development of a condition called "chemotherapy-associated neutropenic enterocolitis" (CANE).

Objective: To determine the risk of CANE associated with the use of each antineoplastic agent.

Methods: The FDA FAERS database of spontaneous adverse reactions was searched for the occurrence of the MedDRA preferred term "neutropenic colitis."

Results: The search resulted in 1134 records of patients (535 [47.3%] females, 479 [42.2%] males, sex not specified in 120 [10.6%]) with neutropenic colitis receiving immunosuppressive chemotherapy. The mean age of patients was 47 (SD 22). 22 antineoplastic agents were found to have a strong association (reported odds ratio [ROR] > 100) with the occurrence of CANE; 9 had ROR < 2.

Conclusion: Drug databases have several limitations in providing updated information about newly approved pharmaceutical adverse events. Signal detection is a diagnostic method recognized as practical in pharmacovigilance. It may be utilized in the FDA's adverse event reporting database and has demonstrated a reasonable predictive performance in signaling adverse events. Our study emphasized the substantial knowledge gap between what we know about the potential risk of CANE caused by antineoplastic agents and the reports of the FDA on their new approved products.