FDA Greenlights Changes for Merck’s Noxafil Antifungal Label

The FDA has approved label changes for two oral formulations of Merck’s antifungal Noxafil following reports of dosing errors by doctors and patients.

The drug labels were revised to indicate that the two oral formulations cannot be substituted for each other, but require a change in dose to help prevent additional medication errors. According to a MedWatch alert, direct milligram-for-milligram substitution can result in drug levels that are lower or higher than intended.

The antifungal is approved in two oral formulations: an oral suspension and a delayed-release tablet. It also is approved as an intravenous solution.

The FDA says it has received 11 reports of incorrect oral formulations being prescribed or dispensed to patients.  As a result, one person died, while another required hospitalization.