Safety profile of carbapenems: Data mining of the FDA adverse events reporting system

Int J Clin Pharmacol Ther. 2021 Apr 26. doi: 10.5414/CP203811. Online ahead of print.


OBJECTIVE: To learn the safety profile of carbapenems and compare suspected adverse drug reactions (ADRs) among carbapenem classes by data mining the FDA adverse event reporting system (FAERS) database.

MATERIALS: This retrospective study described the general characteristics of adverse drug event (ADE) reports related to carbapenems in the FAERS during 2015 - 2018.

METHODS: The 95% confidence intervals (CIs) of proportional reporting ratio (PRR), the reporting odds ratio (ROR), and information component (IC) of Bayesian confidence propagation neural network (BCPNN) were calculated to identify potential safety signals.

RESULTS: A total number of 5,899 reports associated with carbapenems were submitted to the FAERS from January 1, 2015 to December 31, 2018. The most frequently reported ADE associated with carbapenems was drug ineffective (10.51%). Serious ADEs and death associated with carbapenems were reported in 41.24 and 25.12%, respectively. Infections and infestations was the strongest signal detected in both meropenem and imipenem. Nervous system disorders and psychiatric disorders were strongly detected in ertapenem. Hepatobiliary disorders were common in doripenem patients.

CONCLUSION: Carbapenem resistance is alarming in the United States, and carbapenem is more likely to be associated with serious and fatal ADEs among β-lactam antibiotics. Both differences and similarities exist in the safety profile among carbapenems classes. Close attention should be paid to patients with special disease when administrated carbapenems.

PMID:33896448 | DOI:10.5414/CP203811