Does HUMAN RHO IMMUNE GLOBULIN Cause Off label use? 50 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 50 reports of Off label use have been filed in association with HUMAN RHO IMMUNE GLOBULIN (RhoGAM Ultra-Filtered PLUS). This represents 4.1% of all adverse event reports for HUMAN RHO IMMUNE GLOBULIN.
50
Reports of Off label use with HUMAN RHO IMMUNE GLOBULIN
4.1%
of all HUMAN RHO IMMUNE GLOBULIN reports
7
Deaths
28
Hospitalizations
How Dangerous Is Off label use From HUMAN RHO IMMUNE GLOBULIN?
Of the 50 reports, 7 (14.0%) resulted in death, 28 (56.0%) required hospitalization, and 8 (16.0%) 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 HUMAN RHO IMMUNE GLOBULIN. However, 50 reports have been filed with the FAERS database.