Does COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Cause Product use in unapproved indication? 23 Reports in FDA Database

Q: Does COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN cause Product use in unapproved indication?

23 reports of Product use in unapproved indication have been filed with the FDA for COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN, representing 12.3% of all COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN adverse event reports.

Q: How dangerous is Product use in unapproved indication from COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN?

Of 23 reports, 4 (17.4%) resulted in death and 0 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 23 reports of Product use in unapproved indication have been filed in association with COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN. This represents 12.3% of all adverse event reports for COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN.

Reports of Product use in unapproved indication with COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN

12.3%

of all COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN reports

Deaths

Hospitalizations

How Dangerous Is Product use in unapproved indication From COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN?

Of the 23 reports, 4 (17.4%) resulted in death, and 1 (4.3%) were considered life-threatening.

Is Product use in unapproved indication 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, 23 reports have been filed with the FAERS database.

What Other Side Effects Does COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Cause?

No adverse event (33) Off label use (31) Deep vein thrombosis (25) Embolism (23) Ischaemic stroke (21) Pulmonary embolism (16) Drug ineffective for unapproved indication (12) Drug ineffective (10) Haemorrhage (9) Acute kidney injury (8)

What Other Drugs Cause Product use in unapproved indication?

DUPILUMAB (33,452) DICLOFENAC (12,197) METHOTREXATE (8,930) PREDNISONE (7,625) RITUXIMAB (7,519) MYCOPHENOLATE MOFETIL (5,910) ACETAMINOPHEN (5,819) CYCLOPHOSPHAMIDE (5,750) RISPERIDONE (5,551) TACROLIMUS (5,057)

Which COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Alternatives Have Lower Product use in unapproved indication Risk?

COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COAGULATION FACTOR IX RECOMBINANT HUMAN\ISOPROPYL ALCOHOL COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COAGULATION FACTOR VIIA RECOMBINANT HUMAN COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBAMAMIDE COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN vs COBICISTAT

COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Full Profile All Product use in unapproved indication Reports All Drugs Causing Product use in unapproved indication COAGULATION FACTOR IX HUMAN\COAGULATION FACTOR VII HUMAN\COAGULATION FACTOR X HUMAN\PROTHROMBIN Demographics