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September 22, 2015: FDA Issues Drug Safety Communication For Avycaz (ceftazidime and avibactam) Dose Confusion and Medication Errors

The U.S. Food and Drug Administration (FDA) has issued a drug safety communication to the health care community warning of the risk for dosing errors with the intravenous antibacterial Avycaz (ceftazidime and avibactam) due to confusion about the drug strength as displayed on the product’s vial and carton labels. Avycaz vial and carton labels initially displayed the individual strengths of the two active drug 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, the FDA has revised the labels to more clearly indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.

Medication Errors Prompt Avycaz Labeling Revision

According to the FDA, since Avycaz’s approval in February 2015, they have received three reports of medication errors related to the vial and carton labels. The FDA stated “Since Avycaz’s approval in February 2015, FDA received reports of three medication error cases related to confusion on how the strength was displayed on the Avycaz vial and carton labels. Two cases stated that the errors occurred during preparation of the dose in the pharmacy. The third case described 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. Based on the information provided in the reports, FDA is aware that at least one of the patients received a higher-than-intended dose of Avycaz. No adverse events were reported.”

Avycaz is indicated for the treatment of complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options.

Report Drug Adverse Events and Drug Side Effects To The FDA

The FDA also encouraged healthcare professionals and patients to report drug adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by taking the following action:

Submit an Online Report:
Download a reporting 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

Medication Error Lawsuits and Product Liability Lawsuit Help

For more than 30 years, Attorney Eric Weinberg has represented the seriously injured with personal injury recoveries totaling over $800 million on behalf of the firm’s clients.

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Medication errors are preventable. Drug name confusion, poor communication, misinterpreted or sloppy handwriting, improper drug labeling or instructions, poor medical knowledge, a lack of protocol or process, or failure to properly educate a patient can all result in fatal or harmful medication errors. If you or a family member has been injured as a result of medication error and you have a question regarding a medication error lawsuit, you can request a free legal case evaluation from The Weinberg Law Firm by calling us toll free at 1-877-934-6274. Our phones are answered 24/7.

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