Pharmaceutical

FDA warns of dosing errors with antifungal drug Noxafil

ucm479403 359x210 FDA warns of dosing errors with antifungal drug NoxafilReports of hospitalizations and a patient death related to dosing errors with the antifungal medication Noxafil (posaconazole) have prompted the Food and Drug Administration (FDA) to issue a Drug Safety Communication cautioning health care providers that there has been confusion with differences in dosing regimens between two oral formulations of the drug Noxafil.

Noxafil is used to treat or prevent fungal infections such as Aspergillus and Candida, especially in people with weakened immune systems such as those undergoing chemotherapy, stem cell transplantation and those with HIV infections. It is also used to treat a fungal infection called thrush caused by Candida in the mouth or throat area. It is available as an oral suspension, a delayed-release tablet, and an intravenous solution for injection.

Since the approval of Noxafil delayed-release tablets in November 2013, the FDA has received 11 reports of the wrong oral formulation being prescribed and/or dispensed to patients. One case resulted in death, and another case resulted in hospitalization.

According to the reports, these outcomes were the 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.

The FDA is requiring the drug’s maker, Merck, to update the safety labels on the outer carton of Noxafil with revised prescribing information to alert patients and health care professionals that the two oral formulations of Noxafil cannot be substituted for each other.

Any side effects related to dosing errors with Noxafil should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Sources:
FDA
Medscape