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News From the Food and Drug Administration
July 7, 2015

Label Confusion Leads to Errors

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Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2015;314(1):17. doi:10.1001/jama.2015.7109

Medication errors linked with confusion about correctly dosing the antibacterial drug Zerbaxa have led to revisions in the vial and carton labeling.

Zerbaxa received FDA approval in December 2014 to treat adults with complicated intra-abdominal infections and complicated urinary tract infections. The approved label displayed the strength of each individual active ingredient: 1 g of ceftolozane, a cephalosporin, and 0.5 g of tazobactam, a β-lactamase inhibitor. However, the drug should be dosed based on the sum of both ingredients, and other β-lactam/β-lactamase antibacterial drug labels express strength as the sum of the ingredients rather than their individual values.

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