Cefepime and Mortality in Pediatric Acute Myelogenous Leukemia

Abstract

Based on 2 meta-analyses, the Food and Drug Administration issued a communication in 2009 regarding the potential risk of death in patients treated with cefepime. Pediatric patients with acute myelogenous leukemia (AML) have frequent episodes of fever necessitating the use of antibiotics such as cefepime. We evaluated the association of cefepime and other beta-lactam antibiotic exposures with all cause in-hospital mortality in pediatric AML patients. We performed a retrospective cohort study using the Pediatric Health Information System, an inpatient database. Exposure to cefepime, ceftazidime, antipseudomonal penicillin, and carbapenems was evaluated for each 30-day period within the first year from AML diagnosis. Cox regression analysis was used to compute hazard ratios (HR) for death adjusting for demographics, clinical variables, and clustering by hospital. The final analysis used 2 distinct time periods (0-3 months and >3-12 months) to account for variation in proportional hazards over time. No differences between the HRs for mortality were observed for the time period of 0 to 3 months (cefepime vs. ceftazadime: HR=1.33, 95% CI: 0.70-2.52; cefepime vs. antipseudmonal penicillin: HR=0.86, 95% CI: 0.34-2.13; and cefepime vs. carbapenems: HR=1.08, 95% CI: 0.50-2.35) or the time period of >3 to 12 months after diagnosis (cefepime vs. ceftazadime: HR=1.29, 95% CI: 0.53-3.15; cefepime vs. antipseudomonal penicillin: HR=1.08, 95% CI: 0.44-2.66; and cefepime vs. carbapenems: HR=1.03, 95% CI: 0.45-2.33). In this cohort of pediatric AML patients, cefepime exposure in the 30 days preceding death did not result in an increased mortality risk when compared with ceftazidime, antipseudomonal penicillins, or carbapenems.