Novoseven and acute respiratory distress syndrome Patient Reports February 10, 2010



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 What is  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 #4617956-4
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: abdominal pain What is  abdominal pain, acute respiratory distress syndrome, coma, diarrhoea, epilepsy What is  epilepsy, epistaxis, haematemesis, hepatic encephalopathy, hepatic failure. 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 #5118332-0
Novoseven side effect was reported by a Physician from CANADA on Sept 25, 2006. Male patient, 36 years of age, weighting 240.3 lb, was diagnosed with traumatic haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, haematology test abnormal, haemoglobin decreased, platelet count decreased. Novoseven dosage: unknown. Patient recovered.

Novoseven Side Effects Report #5198940-1
Novoseven side effect was reported by a Physician from CANADA on Dec 22, 2006. Male patient, weighting 240.3 lb, was diagnosed with traumatic haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, anoxic encephalopathy, aspiration, atrial thrombosis, haemoglobin decreased, platelet count decreased, pulmonary embolism What is  pulmonary embolism, respiratory arrest, vena cava thrombosis. Novoseven dosage: unknown. During the same period patient was treated with ANCEF, GENTAMYCIN, RANITIDINE, ATROVENT, VENTOLIN, TYLENOL. Patient died on 10/12/2006.


Novoseven Side Effects Report #5258308-6
Novoseven side effect was reported by a Physician from BRAZIL on Mar 02, 2007. Male patient, weighting 264.6 lb, was diagnosed with traumatic haemorrhage, antibiotic level therapeutic, pyrexia, sedation, antibiotic prophylaxis, prophylaxis against gastrointestinal ulcer, antiemetic supportive care, analgesic effect and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, multi-organ failure. Novoseven dosage: unknown. During the same period patient was treated with CEFTRIAXONE, ACETAMINOPHEN, MIDAZOLAM, CEFAZOLIN, DIPIRONA, RANITIDINE, METOCLOPRAMIDE, FENTANYL. Patient was hospitalized. Patient died on 03/02/2007.

Novoseven Side Effects Report #5263391-8
Novoseven side effect was reported by a Physician from BRAZIL on Mar 02, 2007. Male patient, weighting 264.6 lb, was diagnosed with traumatic haemorrhage, antibiotic level therapeutic, pyrexia, sedation, antibiotic prophylaxis, prophylaxis against gastrointestinal ulcer, antiemetic supportive care, analgesic effect and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, multi-organ failure. Novoseven dosage: unknown. During the same period patient was treated with CEFTRIAXONE, ACETAMINOPHEN, MIDAZOLAM, CEFAZOLIN, DIPIRONA, RANITIDINE, METOCLOPRAMIDE, FENTANYL. Patient was hospitalized. Patient died on 03/02/2007.

Novoseven Side Effects Report #5272201-4
Novoseven side effect was reported by a Physician from BRAZIL on Mar 09, 2007. Male patient, weighting 264.6 lb, was diagnosed with traumatic haemorrhage, antibiotic level therapeutic, pyrexia, sedation, antibiotic prophylaxis, prophylaxis against gastrointestinal ulcer, antiemetic supportive care and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, multi-organ failure, sepsis What is  sepsis. Novoseven dosage: unknown. During the same period patient was treated with CEFTRIAXONE, ACETAMINOPHEN, MIDAZOLAM, CEFAZOLIN, DIPIRONA, RANITIDINE, METOCLOPRAMIDE. Patient was hospitalized. Patient died on 03/02/2007.

Novoseven Side Effects Report #5297320-8
Novoseven side effect was reported by a Physician from CANADA on Apr 03, 2007. Male patient, weighting 196.2 lb, was diagnosed with traumatic haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, anoxic encephalopathy, pulmonary embolism What is  pulmonary embolism, vena cava thrombosis. Novoseven dosage: unknown. During the same period patient was treated with ANCEF, GENTAMYCIN, RANITIDINE, ATROVENT, VENTOLIN, TYLENOL. Patient died on 10/12/2006.

Novoseven Side Effects Report #5360266-0
Novoseven side effect was reported by a Physician from BRAZIL on June 11, 2007. Male patient, weighting 264.6 lb, was diagnosed with traumatic haemorrhage, antibiotic level therapeutic, pyrexia, sedation, antibiotic prophylaxis, prophylaxis against gastrointestinal ulcer, antiemetic supportive care and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, multi-organ failure, sepsis What is  sepsis. Novoseven dosage: unknown. During the same period patient was treated with CEFTRIAXONE, ACETAMINOPHEN, MIDAZOLAM, CEFAZOLIN, DIPIRONA, RANITIDINE, METOCLOPRAMIDE. Patient was hospitalized. Patient died on 03/02/2007.


Novoseven Side Effects Report #5160380-9
Novoseven side effect was reported by a Physician from CANADA on Sept 25, 2006. Male patient, weighting 240.3 lb, was diagnosed with traumatic haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, anoxic encephalopathy, aspiration, blood pressure systolic decreased, depressed level of consciousness, eye rolling, haematology test abnormal, haemoglobin decreased, heart rate increased. Novoseven dosage: unknown. During the same period patient was treated with ANCEF, GENTAMYCIN, RANITIDINE, ATROVENT, VENTOLIN, TYLENOL. Patient died on 10/12/2006.

Novoseven Side Effects Report #5174425-3
Novoseven side effect was reported by a Physician from CANADA on Sept 25, 2006. Male patient, weighting 240.3 lb, was diagnosed with traumatic haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, anoxic encephalopathy, haematology test abnormal, pulmonary embolism What is  pulmonary embolism, vena cava thrombosis. Novoseven dosage: unknown. During the same period patient was treated with ANCEF, GENTAMYCIN, RANITIDINE, ATROVENT, VENTOLIN, TYLENOL. Patient died on 10/12/2006.

Novoseven Side Effects Report #5425975-3
Novoseven side effect was reported by a Physician from GERMANY on Aug 20, 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, renal failure acute, thrombosis, venous thrombosis. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ESMERON, PROPOFOL. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #5431279-5
Novoseven side effect was reported by a Physician from GERMANY on Aug 20, 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, renal failure acute, thrombosis, venous thrombosis. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ESMERON, PROPOFOL. Patient was hospitalized. Patient recovered.

Novoseven Side Effects Report #5451135-6
Novoseven side effect was reported by a Physician from GERMANY on Sept 04, 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, blood pressure decreased, body temperature decreased, cerebral haematoma, continuous haemodiafiltration, cyanosis, embolism, heart rate increased, renal failure acute. Novoseven dosage: unknown. During the same period patient was treated with FENTANYL, DORMICUM, LASIX, PANCURONIUM, ESMERON, PROPOFOL. Patient was hospitalized. Patient recovered.


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 What is  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 What is  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 #5624167-2
Novoseven side effect was reported by a Physician from BRAZIL on Feb 01, 2008. Male patient, weighting 264.6 lb, was diagnosed with traumatic haemorrhage, antibiotic level therapeutic, pyrexia, sedation, antibiotic prophylaxis, prophylaxis against gastrointestinal ulcer, antiemetic supportive care and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, alanine aminotransferase increased, aspartate aminotransferase increased, multi-organ failure, sepsis What is  sepsis. Novoseven dosage: unknown. During the same period patient was treated with CEFTRIAXONE, ACETAMINOPHEN, MIDAZOLAM, CEFAZOLIN, DIPIRONA, RANITIDINE, METOCLOPRAMIDE. Patient was hospitalized. Patient died on 03/02/2007.

Novoseven Side Effects Report #5653022-7
Novoseven side effect was reported by a Physician from CANADA on Feb 25, 2008. Male patient, weighting 196.2 lb, was diagnosed with traumatic haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, anoxic encephalopathy, haemoglobin decreased, platelet count decreased, pulmonary embolism What is  pulmonary embolism, tachypnoea, vena cava thrombosis. Novoseven dosage: unknown. During the same period patient was treated with ANCEF, GENTAMYCIN, RANITIDINE, ATROVENT, VENTOLIN, TYLENOL. Patient died on 10/12/2006.

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 What is  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 What is  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 What is  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 What is  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 What is  hepatitis, loss of consciousness, metabolic disorder What is  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 #5101470-6
Novoseven side effect was reported by a Physician from SPAIN on Aug 10, 2006. Female patient was diagnosed with postpartum haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, anuria, haemodynamic instability, multi-organ failure, renal failure, sepsis What is  sepsis. Novoseven dosage: 2.4 MG, SINGLE. Patient was hospitalized. Patient died on 07/17/2006.

Novoseven Side Effects Report #4591014-X
Novoseven side effect was reported by a Pharmacist from on Oct 25, 2004. Male patient, 18 years of age, weighting 187.4 lb, was diagnosed with injury and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, respiratory failure. Novoseven dosage: unknown. Patient was hospitalized. Patient died on 10/08/2004.

Novoseven Side Effects Report #5298827-X
Novoseven side effect was reported by a Physician from AUSTRALIA on Apr 11, 2007. Male patient, 38 years of age, weighting 176.4 lb, was diagnosed with haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, disseminated intravascular coagulation, multi-organ failure. Novoseven dosage: 6 MG, UNK. Patient was hospitalized. Patient died on 10/17/2005.

Novoseven Side Effects Report #5256546-X
Novoseven side effect was reported by a Physician from ISRAEL on Feb 21, 2007. Female patient, 32 years of age, weighting 143.3 lb, was diagnosed with haemorrhage and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, multi-organ failure, pulmonary haemorrhage. Novoseven dosage: 6 MG, SINGLE. During the same period patient was treated with FRESH FROZEN PLASMA, CRYOPRECIPITATES, BLOOD CELLS. Patient died on 01/13/2007.

Novoseven Side Effects Report #5946029-3
Novoseven side effect was reported by a Health Professional from FRANCE on Nov 04, 2008. Male patient was diagnosed with haemorrhage, hypertension and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, condition aggravated, rhabdomyolysis. Novoseven dosage: 4.8 MG, BID. During the same period patient was treated with AMLOD, COTAREG, AUGMENTIN, PERFALGAN, MORPHIN, CALCIUM, PLATELETS. Patient died on 09/18/2008.


Novoseven Side Effects Report #5954890-1
Novoseven side effect was reported by a Health Professional from FRANCE on Nov 07, 2008. Male patient was diagnosed with haemorrhage, hypertension and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, condition aggravated, rhabdomyolysis. Novoseven dosage: 4.8 MG, BID. During the same period patient was treated with AMLOD, COTAREG, AUGMENTIN, PERFALGAN, MORPHIN, CALCIUM, PLATELETS. Patient died on 09/18/2008.

Novoseven Side Effects Report #5276669-9
Novoseven side effect was reported by a Physician from SPAIN on Mar 14, 2007. Male patient, 41 years of age, weighting 176.4 lb, was diagnosed with haemodynamic instability and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, multi-organ failure, necrosis, venous thrombosis. Novoseven dosage: 1.2 MG, 45 MCG/KG. During the same period patient was treated with PLASMA. Patient died on 10/02/2006.

Novoseven Side Effects Report #5334473-7
Novoseven side effect was reported by a Physician from SPAIN on May 16, 2007. Male patient, 41 years of age, weighting 176.4 lb, was diagnosed with haemodynamic instability and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, multi-organ failure, necrosis, venous thrombosis. Novoseven dosage: 1.2 MG, 45 MCG/KG. During the same period patient was treated with PLASMA. Patient died on 10/02/2006.

Novoseven Side Effects Report #5389046-7
Novoseven side effect was reported by a Physician from TURKEY on July 09, 2007. Male patient was diagnosed with disseminated intravascular coagulation and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, disseminated intravascular coagulation, haematoma, haemorrhage intracranial. Novoseven dosage: unknown. During the same period patient was treated with RED BLOOD CELLS, FRESH FROZEN PLASMA, CRYOPRECIPITATES, PLATELETS. Patient died.

Novoseven Side Effects Report #4688675-3
Novoseven side effect was reported by a Physician from on May 20, 2005. Male patient, 21 years of age, was diagnosed with coagulopathy and was treated with Novoseven. After drug was administered, patient experienced the following side effects: acute respiratory distress syndrome, pleural effusion, stenotrophomonas infection. Novoseven dosage: unknown. Patient was hospitalized. Patient recovered.
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side effects of Novoseven