Parenteral amphotericin B: fatal overdose risk due to confusion between lipid-based and non-lipid-based formulations

There is a potential risk of fatal overdose due to confusion between lipid-based and non-lipid-based formulations of parenteral amphotericin B. These formulations are not interchangeable: prescribers, pharmacists, and nurses need to be fully aware of the formulation being used and the associated dose regimen

Article date: April 2010

Parenteral amphotericin B is available as lipid-based and non-lipid-based formulations for the treatment of fungal infections. These different formulations of amphotericin B have different dose requirements.

Cases of fatal overdose have resulted when Fungizone (a non-lipid-based formulation of amphotericin B) has been mistakenly administered instead of a lipid-based formulation. Amphotericin B overdoses may result in potentially fatal cardiac or cardiorespiratory arrest. The total daily dose of Fungizone should not exceed 1·5 mg/kg.

The appropriate dose and method of administration differ markedly between the marketed parenteral formulations of amphotericin B and they are therefore not interchangeable.

Particular care must be taken in prescribing and dispensing the correct parenteral formulation of amphotericin B: prescribers, pharmacists, and nurses need to be fully aware of the formulation being used and the associated dose regimen.

Fungizone packages, cartons, and vial labels are being modified to carry the following cautionary statements:

Fungizone is not interchangeable with other amphotericin products. STOP! Verify product name and dosage. TOTAL DAILY DOSE MUST NOT EXCEED 1·5 MG PER KG.”

A letter was sent to healthcare professionals in March 2010 to notify them of the updates to product information for Fungizone.

Advice for healthcare professionals

Do not exceed a total daily dose of 1·5 mg/kg for Fungizone.

To prevent inadvertent overdose, verify the product name and dose before administration, especially if the dose prescribed exceeds 1·5 mg/kg—the maximum recommended dose for Fungizone.

Suspected adverse reactions associated with amphotericin B should be reported to using the Yellow Card Scheme.

 

Article citation: Drug Safety Update April 2010, vol 3 issue 9: 8.

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