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January 4, 2016: FDA Mandates Label Change to Address Noxafil Medication Error

Noxafil Medication Error News

According to the U.S. Food and Drug Administration (FDA) Drug Safety Communication on January 4, 2016, confusion over the dosing of the antifungal drug Noxafil’s two oral formulations warranted a change in the medication’s label.
Noxafil comes in two oral formulations, in an oral suspension or delayed-release tablet, which cannot be directly substituted milligram for milligram. The FDA has identified eleven cases of dosing errors so far, one case of which resulted in death, and an additional case which resulted in hospitalization.


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Noxafil Medication Error and Label Change

According to the FDA Safety Communication, “these outcomes were a result of health care professionals not knowing that the two oral formulations cannot be substituted for each other without adjusting the dose due to differences in how the medicine is absorbed and handled by the body.”
In an effort to mitigate the risk of medication errors, the FDA ordered that the drug labels on each respective form of Noxafil be revised “to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose.”

Noxafil is used to prevent invasive Aspergillus and Candida fungal infections.

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