FDA Warns of Risk for Dosing Errors With Avycaz

Megan Brooks

September 22, 2015

There is a risk for dosing errors with the intravenous antibacterial combination drug ceftazidime-avibactam (Avycaz, Forest Labs) as a result of confusion about the drug strength displayed on the vial and carton labels, the US Food and Drug Administration (FDA) warns in a drug safety communication.

The agency has taken action to fix the problem by revising the label.

The FDA approved Avycaz in February 2015 to treat complicated urinary tract infections and complicated intra-abdominal infections in combination with metronidazole in patients with limited or no alternative treatment options.

Initially, Avycaz was approved with the vial and carton labels displaying the individual strengths of the two active ingredients (ie, 2 g/0.5 g per vial); however, Avycaz is dosed based on the sum of the active ingredients (ie, 2.5 g).

To prevent medication errors, the FDA has revised the vial and carton labels to indicate that each vial contains Avycaz 2.5 g, which is equivalent to 2 g ceftazidime and 0.5 g avibactam.

Since the drug's approval, the FDA has received three separate reports of medication errors related to confusion on how the strength was displayed on the original Avycaz vial and carton labels. Two cases involved errors that occurred during preparation of the dose in the pharmacy. According to the FDA, at least one of the patients received a higher-than-intended dose of Avycaz, although no adverse events were reported.

In the third case, there was 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.

"Our evaluation determined that previously approved beta-lactam/beta-lactamase antibacterial drug products express the strength as the sum of the two active ingredients in the labels (e.g., 1.5 gram or 3 gram of ampicillin/sulbactam)," the FDA explains in their communication. "Therefore, pharmacists and prescribers are familiar with this convention for expressing the strength of beta-lactam/beta-lactamase antibacterial drugs as the sum of the two active ingredients. Confusion arose when the vial and carton labels of Avycaz expressed the strength to reflect the individual active ingredients."

The drug safety communication includes photos of the old and new label.

The FDA encourages healthcare professionals to report adverse effects and medication errors involving Avycaz to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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