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Review Aprotinin Safety Reports submitted to FDA

Total Aprotinin reports: 29.
Aprotinin FDA safety alerts: 2006 2007 2008 .
Reported deaths: 10    Reported hospitalizations: 10.
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FDA Reported Aprotinin Side Effects: hypotension, renal failure acute, pulmonary oedema, hepatic failure, large intestinal haemorrhage, renal failure, neurological symptom, ileus, fungal sepsis, post procedural complication, intracardiac thrombus.
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Aprotinin Side Effects Report #5647304-2
Health Professional from UNITED STATES reported APROTININ problem on Feb 11, 2008. Male patient, 59 years of age, was diagnosed with ventricular assist device insertion, coagulopathy and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: atrial thrombosis, vena cava thrombosis, venous thrombosis. APROTININ dosage: unknown. During the same period patient was treated with RFVIIA, HEPARIN, PLATELETS, FRESH FROZEN PLASMA, FRESH FROZEN PLASMA, CRYOPRECIPITATED AHF, CRYOPRECIPITATED AHF. Patient recovered.

Aprotinin Side Effects Report #5627646-7
APROTININ problem was reported by a Health Professional from GERMANY on Feb 05, 2008. Male patient, 69 years of age, was diagnosed with haemorrhage, hypocoagulable state and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: anuria, livedo reticularis, skin discolouration, thrombocytopenia, thrombosis, thrombotic microangiopathy. APROTININ dosage: unknown. During the same period patient was treated with FIBRINOGEN. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5636230-0
Health Professional from UNITED STATES reported APROTININ problem on Feb 20, 2008. Male patient, 54 years of age, weighting 152.0 lb, was diagnosed with aortic valve replacement, coronary artery bypass and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: coronary artery thrombosis, graft thrombosis, hypotension, no therapeutic response, ventricular hypokinesia. APROTININ dosage: 50 ML/HR IV 20 MIU IV X 1 PUMP PRIME 2 MILL.KIU - 200 ML. Patient died on 08/24/2006.

Aprotinin Side Effects Report #5583192-0
APROTININ problem was reported by a Pharmacist from UNITED STATES on Jan 03, 2008. Female patient, 61 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: anaphylactoid reaction. APROTININ dosage: unknown. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5505937-8
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Oct 31, 2007. Female patient, 51 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: pulmonary hypertension, renal failure acute, thrombotic thrombocytopenic purpura. APROTININ dosage: unknown. Patient recovered.

Aprotinin Side Effects Report #5505938-X
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 31, 2007. Female patient, 68 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, hyperglycaemia, renal impairment, shock. APROTININ dosage: unknown. Patient died.

Aprotinin Side Effects Report #5505939-1
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Oct 31, 2007. Male patient, 79 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, myocardial infarction, renal failure, shock. APROTININ dosage: unknown. Patient died.

Aprotinin Side Effects Report #5507452-4
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 31, 2007. Male patient, 72 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, renal impairment, renal tubular necrosis, thrombocytopenia. APROTININ dosage: unknown. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5507454-8
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Oct 31, 2007. Female patient, 68 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, hyperglycaemia, renal impairment, shock. APROTININ dosage: unknown. Patient died.

Aprotinin Side Effects Report #5507455-X
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 31, 2007. Male patient, 79 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, myocardial infarction, renal failure, shock. APROTININ dosage: unknown. Patient died.

Aprotinin Side Effects Report #5507456-1
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Oct 31, 2007. Male patient, 83 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: lung disorder, renal failure acute, respiratory disorder, sepsis. APROTININ dosage: unknown. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5507457-3
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 31, 2007. Male patient, 83 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, blood creatine phosphokinase increased, renal failure acute, renal tubular necrosis. APROTININ dosage: unknown. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5507460-3
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Oct 31, 2007. Female patient, 51 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: pulmonary hypertension, renal failure acute, thrombotic thrombocytopenic purpura. APROTININ dosage: unknown. Patient recovered.

Aprotinin Side Effects Report #5473290-4
APROTININ problem was reported by a Health Professional from CANADA on Sept 26, 2007. Male patient, 54 years of age, was diagnosed with heart transplant and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, bronchospasm, coagulopathy, hypotension, oxygen saturation decreased, peripheral ischaemia, pulmonary oedema, rash erythematous, renal failure. APROTININ dosage: unknown. Patient died.

Aprotinin Side Effects Report #5441675-8
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Aug 22, 2007. Male patient, 72 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, renal impairment, renal tubular necrosis, thrombocytopenia. APROTININ dosage: unknown. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5441678-3
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 22, 2007. Male patient, 83 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatine increased, blood creatine phosphokinase increased, renal failure acute, renal tubular necrosis. APROTININ dosage: unknown. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5441679-5
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Aug 22, 2007. Female patient, 68 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, hyperglycaemia, renal impairment, shock. APROTININ dosage: unknown. Patient died.

Aprotinin Side Effects Report #5441680-1
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 22, 2007. Male patient, 83 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: lung disorder, renal failure acute, respiratory disorder, sepsis. APROTININ dosage: unknown. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5441681-3
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Aug 22, 2007. Female patient, 51 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: pulmonary hypertension, renal failure acute, thrombotic thrombocytopenic purpura. APROTININ dosage: unknown. Patient recovered.

Aprotinin Side Effects Report #5441682-5
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 22, 2007. Male patient, 79 years of age, was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, myocardial infarction, renal failure, shock. APROTININ dosage: unknown. Patient died.

Aprotinin Side Effects Report #5462988-X
Health Professional from UNITED STATES reported APROTININ problem on Sept 11, 2007. Female patient, 78 years of age, was diagnosed with aortic valve replacement, blood product transfusion, platelet transfusion and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood lactic acid increased, coagulopathy, haemorrhage, hypotension, intracardiac thrombus, oliguria, pulmonary oedema, ventricular failure. APROTININ dosage: unknown. During the same period patient was treated with PROTAMINE SULPHATE, FRESH FROZEN PLASMA, PLATELETS, RED BLOOD CELLS, LEVOTHYROXINE, TRIAMTERENE. Patient died.

Aprotinin Side Effects Report #5403940-X
APROTININ problem was reported by a Health Professional from IRELAND on Aug 02, 2007. Male patient, 46 years of age, was diagnosed with liver transplant and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, fibrinolysis abnormal, hypotension, tachycardia. APROTININ dosage: unknown. During the same period patient was treated with OCTAPLAS. Patient died.

Aprotinin Side Effects Report #5420636-9
Health Professional from AUSTRALIA reported APROTININ problem on Aug 08, 2007. Male patient, 78 years of age, was diagnosed with prophylaxis, sedation, anaesthesia and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: coronary artery thrombosis, electrocardiogram st segment elevation, myocardial ischaemia. APROTININ dosage: unknown. During the same period patient was treated with PERINDOPRIL ERBUMINE, PROPRANOLOL, GLYBURIDE, METFORMIN, MIDAZOLAM, FENTANYL. Patient was hospitalized. Patient recovered.

Aprotinin Side Effects Report #5461041-9
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 21, 2006. Female patient was diagnosed with spinal fusion surgery and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, renal failure acute, urine output decreased. APROTININ dosage: 1 ML, ONCE, INTRAVENOUS; 200 ML, ONCE, INTRAVENOUS; 50 ML, Q1HR, INTRAVENOUS. During the same period patient was treated with ENALAPRIL MALEATE. Patient recovered.

Aprotinin Side Effects Report #5461042-0
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Dec 21, 2006. Female patient was diagnosed with spinal fusion surgery and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, renal failure acute, urine output decreased. APROTININ dosage: 1 ML, ONCE, INTRAVENOUS; 200 ML, ONCE, INTRAVENOUS; 50 ML, Q1HR, INTRAVENOUS. During the same period patient was treated with BENAZEPRIL HYDROCHLORIDE. Patient recovered.

Aprotinin Side Effects Report #5461044-4
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 21, 2006. Female patient was diagnosed with spinal fusion surgery and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, renal failure acute, urine output decreased. APROTININ dosage: 1 ML, ONCE, INTRAVENOUS; 200 ML, ONCE, INTRAVENOUS; 50 ML, Q1HR, INTRAVENOUS. During the same period patient was treated with LOSARTAN POTASSIUM. Patient recovered.

Aprotinin Side Effects Report #5461046-8
Consumer or non-health professional from UNITED STATES reported APROTININ problem on Dec 21, 2006. Female patient was diagnosed with spinal fusion surgery and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, renal failure acute, urine output decreased. APROTININ dosage: 1 ML, ONCE, INTRAVENOUS; 200 ML, ONCE, INTRAVENOUS; 50 ML, Q1HR, INTRAVENOUS. Patient recovered.

Aprotinin Side Effects Report #5393313-0
APROTININ problem was reported by a Consumer or non-health professional from UNITED STATES on July 20, 2007. Male patient was diagnosed with cardiac operation and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. APROTININ dosage: unknown. Patient recovered.

Aprotinin Side Effects Report #5393313-0
Consumer or non-health professional from UNITED STATES reported APROTININ problem on July 20, 2007. Male patient was diagnosed with cardiac operation and was treated with APROTININ. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. APROTININ dosage: unknown. Patient recovered.


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atrial thrombosis, vena cava thrombosis, venous thrombosis, anuria, livedo reticularis, skin discolouration, thrombocytopenia, thrombosis, thrombotic microangiopathy, , was diagnosed with ventricular assist device insertion, coagulopathy and was diagnosed with haemorrhage, hypocoagulable state and