Does INVESTIGATIONAL PRODUCT Cause Off label use? 58 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 58 reports of Off label use have been filed in association with INVESTIGATIONAL PRODUCT. This represents 1.1% of all adverse event reports for INVESTIGATIONAL PRODUCT.
58
Reports of Off label use with INVESTIGATIONAL PRODUCT
1.1%
of all INVESTIGATIONAL PRODUCT reports
8
Deaths
39
Hospitalizations
How Dangerous Is Off label use From INVESTIGATIONAL PRODUCT?
Of the 58 reports, 8 (13.8%) resulted in death, 39 (67.2%) required hospitalization, and 5 (8.6%) 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 INVESTIGATIONAL PRODUCT. However, 58 reports have been filed with the FAERS database.