FDA Drug Safety Communication

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FDA Date: 9/22/15

Avycaz (ceftazidime and avibactam) FDA Drug Safety Communication

FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam)

The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, we have revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.

Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness.

Since Avycaz's approval in February 2015, we have received reports of three medication error cases related to confusion on how the strength was displayed on the Avycaz vial and carton labels. Two cases stated that the errors occurred during preparation of the dose in the pharmacy. The third case described concern about the potential for confusion because the strength displayed for Avycaz differs from how the strength is displayed for other beta-lactam/beta-lactamase antibacterial drugs. Based on the information provided in the reports, we are aware that at least one of the patients received a higher-than-intended dose of Avycaz. No adverse events were reported.

View the full FDA Drug Safety Communication on FDA.gov