The U.S. Food and Drug Administration has published a safety announcement warning healthcare professionals about discrepancies between two oral formulations for the antifungal Noxafil that have resulted in 11 dosing errors, one hospitalization and one death.
Noxafil has two approved oral formulations — an oral suspension and a delayed-release tablet — and an intravenous solution for injection.
The errors the FDA identified were the result of "healthcare 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," according to the federal report.
As a result of the adverse events, Noxafil manufacturer Merck revised the label to indicate the necessary dose change. That said, the FDA still made the following three suggestions to avoid future errors:
1. Noxafil prescribers should specify dosage form, strength and frequency on all prescriptions
2. Pharmacists should clarify the dosage form, strength or frequency with providers if the prescription does not include any of the necessary information
3. Patients should contact their physician or a healthcare professional before changing from one oral formulation to another
To read the full FDA safety announcement, click here.
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