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Dose Confusion Can Occur With Avycaz, FDA Warns

Medication errors are possible with ceftazidime/avibactam combo

Health care professionals should be alert to the risk for dosing errors with the intravenous antibacterial drug ceftazidime/avibactam (Avycaz, Forest Pharmaceuticals Inc.) due to confusion about the drug strength displayed on the vial and carton labels, the FDA says.

Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (e.g., 2 g/0.5 g); however, the product is dosed based on the sum of the active ingredients (e.g., 2.5 g). To prevent medication errors, the agency revised the labels to indicate that each vial contains Avycaz 2.5 g, equivalent to ceftazidime 2 g and avibactam 0.5 g.

Since Avycaz’s approval in February 2015, the FDA has received reports of three medication error cases related to confusion about how the strength was displayed on the Avycaz vial and carton labels. In two cases, the errors occurred during preparation of the dose in the pharmacy. The third case involved 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 drugs.

At least one patient received a higher-than-intended dose of Avycaz. No adverse events were reported.

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.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Source: FDA, September 22, 2015.

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