Does ASCORBIC ACID\POLYETHYLENE GLYCOL 4000\POTASSIUM CL\SOD ASCORBATE\SOD CL\SOD Cause Off label use? 5 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 5 reports of Off label use have been filed in association with ASCORBIC ACID\POLYETHYLENE GLYCOL 4000\POTASSIUM CL\SOD ASCORBATE\SOD CL\SOD. This represents 25.0% of all adverse event reports for ASCORBIC ACID\POLYETHYLENE GLYCOL 4000\POTASSIUM CL\SOD ASCORBATE\SOD CL\SOD.
How Dangerous Is Off label use From ASCORBIC ACID\POLYETHYLENE GLYCOL 4000\POTASSIUM CL\SOD ASCORBATE\SOD CL\SOD?
Of the 5 reports, 2 (40.0%) resulted in death, 5 (100.0%) required hospitalization, and 2 (40.0%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for ASCORBIC ACID\POLYETHYLENE GLYCOL 4000\POTASSIUM CL\SOD ASCORBATE\SOD CL\SOD. However, 5 reports have been filed with the FAERS database.