Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors

[Posted 05/20/2015]

AUDIENCE: Nursing, Pharmacy, Risk Manager

ISSUE: The U.S. Food and Drug Administration (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. (See the Drug Safety Communication for Label Photos).

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

BACKGROUND: Zerbaxa is used to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness.

RECOMMENDATION: FDA urges health care professionals and patients to report side effects and medication errors involving Zerbaxa to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Drug Safety Communication, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm447629.htm