Concern over Dosing Errors Prompts Revised Labels for Antibacterial Combination Drug Avycaz

The Food and Drug Administration (FDA) has ordered revised labels for the intravenous antibacterial combination drug Avycaz (ceftazidime-avibactam) made by Forest Labs because of reports of dosing errors.

The risk of dosing errors arose because of confusion about the drug strength displayed on the vial and carton labels, according to the FDA drug safety announcement. The labels will be revised to make them consistent with the labels of similar combination drugs.

Avycaz received FDA approval 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), but 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.

In the months 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. The FDA says least one patient received a higher-than-intended dose of Avycaz, although no adverse events have been 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.

In the safety communication the FDA explains, “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).” Prescribers and pharmacists are familiar with the convention for expressing the strength of beta-lactam/beta-lactamase antibacterial drugs as the sum of the two active ingredients. Confusion occurred with Avycaz labels expressing the strength of the individual active ingredients. Photos of the old and new labels can be accessed on the FDA web site.

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

 

from Parker Waichman http://www.yourlawyer.com/blog/concern-over-dosing-errors-prompts-revised-labels-for-antibacterial-combination-drug-avycaz/