Adverse events induced by anti-infectives in hospitalized patients

Introduction. Th e objective of this study was to obtain accurate data about adverse events (AEs) related to antimicrobial therapy, including rate, causality, outcome and circumstances in which they occurred. Methods. Hospitalizised patients undergoing treatment with one or more anti-infective drugs were eligible for the study. Th e main outcome measures were any adverse clinical signs, symptoms or laboratory test abnormalities that had likely been induced by an anti-infective agent. Th e seriousness and causality of the AEs were classifi ed on the basis of WHO recommendations and compared with results from the Naranjo Probability Scale, European Causality Categories (ABO system) and French Imputation System assessments. Results. During the 6-month study period, 421 patients (72.84%) received at least one anti-infective drug. Th irtyone patients (7.36%) were found to have anti-infectiveinduced AEs. Anti-tuberculosis agents caused the highest percentage of AEs (38.7%) during the period of observation. Th e majority of AEs presented as disorders of the gastrointestinal tract (41.9%). Conclusion. AEs in females tend to last longer than in males. Males have a greater risk of experiencing AEs caused by fluoroquinolones (e.g., ciprofloxacin), while female patients have a greater risk of experiencing AEs caused by anti-tuberculosis agents. The incidence of AEs in inpatients receiving anti-infectives in our study (7.36%) is within the range reported from other studies. There is a great need for the development of new causality assessment scales that have better sensitivity and specificity.