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FDA Orders Revised Label for Antibacterial Combination Drug Avycaz to Prevent Dosing Errors

Sep 23, 2015

The Food and Drug Administration (FDA) has issued a drug safety communication warning of the risk of dosing errors with the intravenous antibacterial combination drug Avycaz (ceftazidime-avibactam) made by Forest Labs.

The risk of dosing errors is a result of confusion about the drug strength displayed on the vial and carton labels, the FDA warns. 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 (2 g/0.5 g per vial); however, Avycaz is dosed based on the sum of the active ingredients (2.5 g), the safety announcement says.

To prevent medication errors, the FDA has ordered revised 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 Avycaz was approved, the FDA has received three separate reports of medication errors involving confusion about how the strength was displayed on the 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 patient received a higher-than-intended dose of Avycaz, although no adverse events were reported. In the third case, the FDA says, 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 the safety communication. 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 Avycaz vial and carton labels expressed the strength to reflect the individual active ingredients.

The drug safety communication, available on the FDA web site, includes photos of the old and new label.

The FDA encourages health care professionals to report adverse effects and medication errors involving Avycaz through the MedWatch safety information and adverse event reporting program: Reports may also be made by mail, by telephone at 1-800-FDA-1088, or by fax at 1-800-FDA-0178.

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