Novoseven and hepatic failure Patient Reports February 11, 2012

Novoseven Side Effects Report #4571386-2
Novoseven side effect was reported by a Physician from on Jan 24, 2005. Female patient, 72 years of age, weighting 143.3 lb, was diagnosed with upper gastrointestinal haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic failure, hepatitis alcoholic, hepatotoxicity. Novoseven dosage: unknown. During the same period patient was treated with OBSIDAN, TOREM, OMEPRAZOLE, SPIRONOLACTONE, LACTULOSE, KONAKION, SOMATOSTATIN. Patient recovered.

Novoseven Side Effects Report #4586994-2
Novoseven side effect was reported by a Physician from on Jan 24, 2005. Female patient, 72 years of age, weighting 143.3 lb, was diagnosed with upper gastrointestinal haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic cirrhosis, hepatic failure, hepatic steatosis, hepatitis alcoholic, hepatotoxicity. Novoseven dosage: unknown. During the same period patient was treated with OBSIDAN, TOREM, SPIRONOLACTONE, LACTULOSE, KONAKION, SOMATOSTATIN. Patient recovered.

Novoseven Side Effects Report #4625035-5
Novoseven side effect was reported by a Physician from on Jan 24, 2005. Female patient, 72 years of age, weighting 158.7 lb, was diagnosed with upper gastrointestinal haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic cirrhosis, hepatic failure, hepatic steatosis, hepatitis alcoholic, hepatorenal syndrome, thrombocytopenia. Novoseven dosage: unknown. During the same period patient was treated with OBSIDAN, TOREM, SPIRONOLACTONE, LACTULOSE, KONAKION, SOMATOSTATIN, AVELOX. Patient died on 02/24/2005.

Novoseven Side Effects Report #4649253-5
Novoseven side effect was reported by a Physician from on Jan 24, 2005. Female patient, 72 years of age, weighting 143.3 lb, was diagnosed with upper gastrointestinal haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic failure, hepatic steatosis, hepatorenal syndrome, thrombocytopenia. Novoseven dosage: unknown. During the same period patient was treated with OBSIDAN, TOREM, SPIRONOLACTONE, LACTULOSE, KONAKION, SOMATOSTATIN, AVELOX. Patient was hospitalized. Patient recovered.


Novoseven Side Effects Report #4568220-3
Novoseven side effect was reported by a Physician from on Nov 23, 2004. Male patient, 53 years of age, weighting 110.2 lb, was diagnosed with upper gastrointestinal haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, coma, epilepsy , epistaxis, hepatic encephalopathy, hepatic failure, pneumonia aspiration, septic shock, status epilepticus. Novoseven dosage: unknown. During the same period patient was treated with SANDOSTATIN, OFLOCET, ERYTHROMYCIN, AUGMENTIN, PHENOBARBITAL. Patient died on 12/02/2004.

Novoseven Side Effects Report #5521736-5
Novoseven side effect was reported by a Physician from GERMANY on Nov 09, 2007. Female patient was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5576439-8
Novoseven side effect was reported by a Physician from GERMANY on Dec 18, 2007. Female patient was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5668920-8
Novoseven side effect was reported by a Physician from GERMANY on Mar 06, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5674101-4
Novoseven side effect was reported by a Physician from GERMANY on Mar 14, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cerebral haematoma, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.


Novoseven Side Effects Report #5822272-9
Novoseven side effect was reported by a Physician from GERMANY on July 21, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, cyanosis, embolism, hepatic failure, hydrocephalus , renal failure acute, subarachnoid haemorrhage, venous thrombosis, venous thrombosis limb. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #5897584-3
Novoseven side effect was reported by a Physician from GERMANY on Sept 18, 2008. Male patient, weighting 187.4 lb, was diagnosed with traumatic haemorrhage, cardiovascular insufficiency, analgesia, anaesthesia, prophylaxis, sedation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, brain oedema, continuous haemodiafiltration, cyanosis, embolism, hepatic failure, hydrocephalus , necrosis, renal failure acute. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ROCURONIUM BROMIDE, PROPOFOL. Patient was hospitalized and became disabled. Patient died on 10/31/2007.

Novoseven Side Effects Report #4972844-9
Novoseven side effect was reported by a Physician from TURKEY on Apr 03, 2006. Female patient, child 2 years of age, was diagnosed with prophylaxis and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, hepatic failure, hepatitis , loss of consciousness, metabolic disorder , pulmonary haemorrhage. Novoseven dosage: unknown. During the same period patient was treated with FRESH FROZEN PLASMA. Patient died on 03/31/2006.

Novoseven Side Effects Report #4987587-5
Novoseven side effect was reported by a Physician from TURKEY on Apr 03, 2006. Female patient, child 2 years of age, weighting 28.66 lb, was diagnosed with prophylaxis and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, bradycardia, hepatic failure, pulmonary haemorrhage. Novoseven dosage: unknown. During the same period patient was treated with FRESH FROZEN PLASMA, RED BLOOD CELLS, BICARBONAT. Patient died on 03/31/2006.

Novoseven Side Effects Report #5159473-1
Novoseven side effect was reported by a Physician from SPAIN on Nov 03, 2006. Female patient, weighting 196.2 lb, was diagnosed with post procedural haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: atelectasis, cardiac tamponade, coagulopathy, haemodialysis, haemodynamic instability, hepatic failure, renal failure acute, respiratory failure, septic shock. Novoseven dosage: unknown. During the same period patient was treated with ENOXAPARIN, ASPIRIN, ACENOCUMAROL, CEFTRIAXONE, FLUCONAZOLE, LINEZOLID, IMIPENEM. Patient was hospitalized. Patient recovered.


Novoseven Side Effects Report #5213233-1
Novoseven side effect was reported by a Health Professional from GERMANY on Jan 05, 2007. Male patient, 59 years of age, weighting 198.4 lb, was diagnosed with operative haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: cholecystitis infective, deep vein thrombosis , hepatic failure, intestinal gangrene, renal failure acute, septic shock. Novoseven dosage: unknown. During the same period patient was treated with MINIRIN, FRESH FROZEN PLASMA, RED BLOOD CELLS, PLATELETS, NOREPINEPHRINE BITARTRATE, DOBUTREX, OPIAT. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #4995643-0
Novoseven side effect was reported by a Health Professional from GERMANY on Oct 16, 2002. Male patient, 59 years of age, weighting 198.4 lb, was diagnosed with operative haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: cholecystitis infective, deep vein thrombosis , hepatic failure, hepatic haemorrhage, intestinal gangrene, liver transplant , operative haemorrhage, renal failure acute, septic shock. Novoseven dosage: unknown. During the same period patient was treated with MINIRIN, FRESH FROZEN PLASMA, RED BLOOD CELLS, PLATELETS, NOREPINEPHRINE BITARTRATE, DOBUTREX. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #5455318-0
Novoseven side effect was reported by a Pharmacist from JAPAN on Sept 12, 2007. Female patient was diagnosed with haemorrhage intracranial and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic failure. Novoseven dosage: 4.8 MG, UNK. Patient died on 09/06/2007.

Novoseven Side Effects Report #5952899-5
Novoseven side effect was reported by a Physician from SPAIN on Nov 05, 2008. Female patient was diagnosed with haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic failure, ischaemia. Novoseven dosage: unknown. Patient recovered.

Novoseven Side Effects Report #5449915-6
Novoseven side effect was reported by a Pharmacist from JAPAN on Sept 07, 2007. Female patient was diagnosed with factor viii deficiency and was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic failure. Novoseven dosage: 4.8 MG, UNK. Patient died.


Novoseven Side Effects Report #5613717-8
Novoseven side effect was reported by a Physician from CHILE on Jan 29, 2008. Female patient was treated with Novoseven. After drug was administered, patient experienced the following side effects: hepatic failure. Novoseven dosage: 4.8 MG, UNK. Patient died on 01/19/2008.