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FDA Cautions About Dose Confusion and Medication Errors With Antibacterial Drug Zerbaxa (Ceftolozane/Tazobactam)

Agency corrects dosing description on vial label

The FDA is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling.

Zerbaxa’s vial label was initially approved with a strength that reflects each individual active ingredient (e.g., 1 g/0.5 g); however, the product is dosed based on the sum of these ingredients (e.g., 1.5 g). To prevent future medication errors, the strength on the drug labeling has been revised to reflect the sum of the two active ingredients. Thus, one vial of Zerbaxa will now list the strength as 1.5 grams equivalent to ceftolozane 1 gram and tazobactam 0.5 gram.

Zerbaxa was approved in December 2014 as monotherapy to treat complicated urinary tract infections, or in combination with metronidazole to treat complicated abdominal infections.

The FDA evaluated seven reported cases of medication errors that occurred during preparation of the dose in the pharmacy because of confusion with the display of the strength of individual ingredients on Zerbaxa’s vial label and carton labeling. Listing the individual drug strengths led to confusion because it was different from the labeling for other beta-lactam/beta-lactamase antibacterial drugs that express strength as the sum of the two active ingredients. In some cases, this led to the administration of 50% more drug than was prescribed. No adverse events were reported among these seven cases.

The FDA urges health care professionals to report adverse effects and medication errors involving Zerbaxa to the FDA MedWatch program.

Source: FDA; May 20, 2015.


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