(295) Use of antibacterials and suspected acute renal failure in Brazil: pharmacovigilance analysis, 2018-2023

Background: Pharmacovigilance analyses about the risk of acute renal failure due to antibacterials are not available in Brazil, mainly due to lack of accessible data. Since 2018 VigiMed – the Brazilian version of VigFlow – was adopted as the official pharmacovigilance system, making such analyses possible.

Objectives: To investigate the occurrence of acute renal failure suspected to be caused by antibacterials in Brazil.

Methods: This is a case/non-case study, based on disproportionality analysis from reports submitted to VigiMed from December 2018 to April 2023. Primary outcome was the frequency of acute renal failure, considering the following preferred terms: ‘renal impairment’, ‘abnormal creatinine clearance’, ‘creatinine clearance decreased’, ‘renal tubular dysfunction’, ‘prerenal failure’, ‘renal failure’, ‘kidney injury’, ‘acute kidney injury’, ‘acute tubular injury’ and ‘acute tubular necrosis’. Drugs belonging to the subgroup J01 from the Anatomical Therapeutic Chemical classification comprised the exposure. Descriptive statistics were obtained and the unadjusted reporting odds ratio (ROR) and 95% confidence intervals (95%CI) of acute renal failure by antibacterials in comparison to other drugs were calculated taking p< 0.05 as significant. Analyses were performed in Stata (v.14.2).

Results: In total, 161,685 suspected adverse drug reactions were reported, most in 2021 (40.5%), from the Southeast region (65.0%), in adults (62.8%), and females (61.9%). Antibacterials comprised 10.8% of suspected drugs reported. Acute renal failure was higher in the elderly (ROR 2.69, 95%CI 1.94-3.72), males (ROR 1.91, 95%CI 1.68-2.17), and with antibacterial’s use (ROR 2.62, 95%CI 2.27-3.01) in comparison to all other drugs reported. Among antibacterials, acute renal failure was higher with amikacin (ROR 13.48, 95%CI 9.19-19.79), azithromycin (ROR 2.17, 95%CI 1.12-4.21), ceftazidime (ROR 3.60, 95%CI 1.48-8.75), daptomycin (ROR 7.61, 95%CI 3.35-17.30), erythromycin (ROR 4.84, 95%CI 1.53-15.29), gentamicin (ROR 5.91, 95%CI 3.14-11.14), linezolid (ROR 4.40, 95%CI 2.26-8.55), piperacillin and tazobactam (ROR 2.96, 95%CI 2.11-4.16), polymyxin b (ROR 8.58, 95%CI 6.39-11.51), teicoplanin (ROR 2.49, 95%CI 1.11-5.6), tigecycline (ROR 5.78, 95%CI 2.36-14.14) and vancomycin (ROR 6.66, 95%CI 5.42-8.18).

Conclusions: Antibacterials increased the chance of reporting acute renal failure in Brazil, which was also higher among the elderly and men. Some agents presented a considerable risk and may require proper monitoring. Additional analyzes adjusting for confounding factors will be performed in the future.