FDA WARNING

FDA Issues Medication Error Warning for Antibacterial Drug

September 23, 2015

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a safety warning for ceftazidime and avibactam (Avycaz) in the wake of medication error reports.

The agency issued the warning to alert healthcare professionals of the possibility of dosing errors that could result from confusion regarding the strength of the drug ingredients on the carton and vial labels.

The drug safety communication reads:

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

The medication is indicated both for the treatment of complicated urinary tract infections as well as a combo therapy (with metronidazole) for patients with complicated abdominal infections who have limited or no alternative therapy options.

The medication was approved in February 2015.

Click here to read the full warning.

 

--Stephanie Vaccaro

 

Reference:

1. U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam). www.fda.gov. 2015 Sep 22.