Does COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Cause Off label use? 31 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 31 reports of Off label use have been filed in association with COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN. This represents 16.6% of all adverse event reports for COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN.
How Dangerous Is Off label use From COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN?
Of the 31 reports, 10 (32.3%) resulted in death, 8 (25.8%) required hospitalization, and 7 (22.6%) 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 COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN. However, 31 reports have been filed with the FAERS database.