Safety Profile of Aztreonam in Clinical Trials

Abstract

The clinical safety of aztreonam in the treatment of suspected aerobic gram-negative infections was assessed in 346 patients who received single doses and in 2,388 patients who received multiple doses. Of those administered multiple doses, 163 (6.8%) experienced 172 adverse clinical effects. The most common were local reactions at the injection site, rash, diarrhea, and nausea and/or vomiting. Among aztreonam and control groups, threefold increases in serum aspartate aminotransferase (SGOT) and serum alanine aminotransferase (SOPT) values occurred at comparably low frequencies; the mean values of SOOT and SOPT were slightly higher in patients administered aztreonam than in those given cefamandole. Treatment with aztreonam was discontinued in 51 (2.1%) of 2,388 patients because of adverse clinical effects or abnormal laboratory test values. Suprainfections (infections due to new pathogens occurring at the original site of infection during treatment with the study drug that weretreated with another antibiotic) werereported in 2%–6% of aztreonam-treated patients, a frequency similar to that observed in control groups. Aztreonam is welltolerated and has a safety profile similar to that of other β-lactam antibiotics.