THROMBIN for Tissue sealing: Side Effects & Safety Data
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There are 10 adverse event reports in the FDA FAERS database where THROMBIN was used for Tissue sealing.
Most Reported Side Effects for THROMBIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Haemorrhage | 19 | 10.0% | 6 | 4 |
| Treatment failure | 15 | 7.9% | 0 | 0 |
| Anaphylactic reaction | 13 | 6.8% | 1 | 1 |
| Factor v inhibition | 12 | 6.3% | 0 | 1 |
| Activated partial thromboplastin time prolonged | 11 | 5.8% | 3 | 2 |
| Product use issue | 11 | 5.8% | 0 | 9 |
| Prothrombin time prolonged | 10 | 5.3% | 3 | 2 |
| Shock | 10 | 5.3% | 2 | 0 |
| Drug ineffective | 9 | 4.7% | 3 | 4 |
| Haemothorax | 9 | 4.7% | 1 | 2 |
| Hypotension | 9 | 4.7% | 1 | 2 |
| Incorrect route of product administration | 9 | 4.7% | 5 | 2 |
| Tonsil cancer | 9 | 4.7% | 0 | 8 |
| Appetite disorder | 8 | 4.2% | 0 | 8 |
| Diarrhoea | 8 | 4.2% | 0 | 8 |
Other Indications for THROMBIN
Haemostasis (52)
Product used for unknown indication (20)
Post procedural haemorrhage (16)
Surgery (12)
Vascular pseudoaneurysm (6)
Haemorrhage (5)
Other Drugs Used for Tissue sealing
FIBRINOGEN HUMAN\THROMBIN HUMAN (226)
DEVICE\GELATIN (18)
APROTININ\CALCIUM\FIBRINOGEN HUMAN\FACTOR XIII CONCENTRATE \THROMBIN (14)
FIBRINOGEN HUMAN\HUMAN THROMBIN (11)
APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN (8)