FDA modifies labels for Avycaz after medication errors

The FDA issued a safety announcement today to warn health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz after errors were reported due to confusion on drug strengths displayed on the vial and carton labels.

Avycaz (ceftazidime/avibactam, Actavis) originally was approved with the labels displaying the individual strengths of its two active ingredients (ie, 2 g/0.5 g). However, the FDA reported that the doses are based on the sum of the active ingredients (ie, 2.5 g). The agency decided to reword the labels to specify that each dose contains Avycaz 2.5 g, equivalent to ceftazidime 2 g and avibactam 0.5 g.

Avycaz was approved in February for the treatment of complicated intra-abdominal infections, in combination with metronidazole, as well as for the treatment of complicated urinary tract infections, including kidney infections. Ceftazidime received approval based on safety and efficacy data. Avibactam was approved based on in vitro studies and animal models, according to a press release.

Since the approval, the FDA was notified of three medication error cases. Two cases reported that the errors occurred during preparation in the pharmacy. The third case expressed concern over how the strength was displayed for ceftazidime/avibactam because it was different from how the strength is displayed for other beta-lactam/beta-lactamase drugs. The FDA reported that at least one patient received a higher-than-intended dose, although no adverse events were reported.

Health care professionals and patients are urged to report adverse events and medication errors associated with ceftazidime/avibactam to the FDA MedWatch program.