FDA MedWatch – Noxafil (posaconazole): Drug Safety Communication – Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved
On January 4, 2016, the FDA (“United States Food and Drug Administration”) published a Drug Safety Communication cautioning healthcare professionals and patients about the differences in dosing regimens between two oral formulations of Noxafil (posaconazole) an antifungal used to treat fungal infections caused by Aspergillus and Candida fungi. FDA Safety Alert on Noxafil
There are two approval oral formulations of Noxafil, an oral delayed release tablet and a liquid oral suspension. The oral tablets we approved in November 2013. Since this time, the FDA has received at least 11 reports of wrong formulations being prescribed or dispensed to patients. It’s reported that these errors resulted from health care professionals not knowing that the two formulations could not be substituted without adjusting the doses resulting in lower or higher than needed drug levels. Of these 11 reports one case resulted in death and another resulted in hospitalization.
If you or a loved one suffered injuries that you believe were caused by Noxafil (prosaconazole) contact one of the experienced dangerous drug attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today