Avycaz Carries Risk of Dosing Errors, FDA Warns

The U.S. Food and Drug Administration (FDA) is warning the antibacterial combination drug Avycaz (ceftazidime-avibactam) manufactured by Forest Labs carries a risk of dosing errors. The potential for confusion stems from the drug strength displayed on the vial and carton labels, the agency said. The FDA is revising the label to address the problem.

Avycaz was approved in February to treat complicated urinary tract infections and complicated intra-abdominal infections in combination with metronidazole. The FDA approved this use in patients who have limited or no other options.

The approved label displays the individual strengths of each active ingredient (i.e. 2 g/ 0.5 g per vial). The approved dosage for Avycaz, however, is based on the sum of the active ingredients (i.e. 2.5 g). The FDA is changing the label to clearly show that each vial contains 2.5 g of Avycaz per vial (equal to 2 g ceftazidime and 0.5 g avibactam).

The FDA has received three reports of medication errors since the drug was approved, Medscape reports. Two errors occurred while dosages were prepared in the pharmacy. The FDA says at least one patient received a a higher dose than intended, but no injuries have been reported thus far.

“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 says in their notification. “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.”

This entry was posted in Legal News. Bookmark the permalink.

© 2005-2018 Parker Waichman LLP ®. All Rights Reserved.