Avycaz Dose Confusion Leads to FDA Medication Error Warning

Government health officials have issued a new warning about the risk of dosing errors with Avycaz, after at least three patients were administered incorrect amounts of the antibacterial drug . 

The FDA issued a drug safety communication on September 22, urging healthcare professionals to exercise caution when administering the intravenous drug Avycaz, warning that the label displays the individual strengths of the two active ingredients, not the sum of both. This may increase the risk of potentially dangerous overdoses.

To date, the FDA has received three reports of patients receiving incorrect dosages due to the ambiguity of the strength displayed on the vials labels.

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Avycaz (ceftazidime and avibactam) is an intravenous antibacterial drug used for the treatment of complicated abdominal, urinary tract, and kidney infections. The drug is administered intravenously to patients only by healthcare professionals.

The reports involving Avycaz dose errors were apparently caused by confusion over the strengths displayed on the vial and carton labels. Avycaz contains two active ingredients, 2 grams ceftazidime and .5 grams avibactam. The labels on the vials display the individual strengths of the two ingredients in “2 gram/0.5 gram” format.

In the three incident reports, doctors reportedly misunderstood that the product was based on the sum of the two ingredients, resulting in incorrect dosages administered.

The FDA stated that two errors occurred during the preparation of the dose in the pharmacy and the third case indicated a patient received a higher than intended dose. To date, no injuries or adverse events have been reported.

Despite the risk, the federal regulators are not calling for an Avycaz recall, but rather warning healthcare providers and revising the labels to indicate that the dosage is based on the sum of the two ingredients.

The label revision now indicates that each vial contains 2.5 grams of Avycaz, which is equivalent to 2 grams of ceftazidime and 0.5 grams of avibactam.


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