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Review Integrilin Safety Reports submitted to FDA

Total Integrilin reports: 30.
Integrilin FDA safety alerts: No.
Reported deaths: 8    Reported hospitalizations: 11.
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FDA Reported Integrilin Side Effects: thrombocytopenia, haemorrhage intracranial, thrombosis, platelet count decreased, retroperitoneal haemorrhage, petechiae, haemoptysis, haematemesis, hypotension, gastrointestinal haemorrhage, injection site haemorrhage.
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Integrilin Side Effects Report #5650059-9
Physician from UNITED STATES reported INTEGRILIN problem on Feb 18, 2008. Female patient was diagnosed with acute coronary syndrome and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: paralysis, spinal cord haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with COUMADIN. Patient recovered.

Integrilin Side Effects Report #5679821-3
INTEGRILIN problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 12, 2008. Female patient, 72 years of age, weighting 140.0 lb, was diagnosed with stent placement, myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: agitation, aortic arteriosclerosis, aortic valve incompetence, arteriosclerosis coronary artery, blood culture positive, bradycardia, brain herniation, bronchiolitis, cerebral arteriosclerosis. INTEGRILIN dosage: 5.6 ML; ONCE; INBO; 3.8 ML; QH; INDRP; 5.6 ML; ONCE; INBO. During the same period patient was treated with LOVENOX, TENECTEPLASE, ASPIRIN, PLAVIX, HEPARIN, CHLORIDE. Patient was hospitalized. Patient died on 08/24/2004.

Integrilin Side Effects Report #5690121-8
Physician from UNITED STATES reported INTEGRILIN problem on Mar 31, 2008. Male patient, 84 years of age, weighting 165.3 lb, was diagnosed with acute coronary syndrome and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. INTEGRILIN dosage: unknown. Patient recovered.

Integrilin Side Effects Report #5615364-0
INTEGRILIN problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 24, 2008. Female patient was diagnosed with coronary arterial stent insertion and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: gingival bleeding, haematemesis, haemoptysis, pleural effusion, pulmonary haemorrhage, pulmonary thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with TENECTEPLASE, LOVENOX. Patient was hospitalized. Patient recovered.

Integrilin Side Effects Report #5630339-3
Consumer or non-health professional from UNITED STATES reported INTEGRILIN problem on Feb 04, 2008. Female patient, 72 years of age, weighting 140.0 lb, was diagnosed with stent placement, myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, aortic arteriosclerosis, aortic valve incompetence, arteriosclerosis coronary artery, atelectasis, bradycardia, bronchiolitis, cardiomegaly, cerebral arteriosclerosis. INTEGRILIN dosage: 5.6 ML;ONCE;INBO, 3.8 ML;QH;INDRP, 5.6 ML;ONCE;INBO. During the same period patient was treated with LOVENOX, TENECTEPLASE, ASPIRIN, PLAVIX, HEPARIN, CHLORIDE. Patient was hospitalized. Patient died on 08/24/2004.

Integrilin Side Effects Report #5640119-0
INTEGRILIN problem was reported by a Pharmacist from UNITED STATES on Feb 26, 2008. Female patient, weighting 106.0 lb, was diagnosed with acute myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, facial palsy, haemorrhage intracranial, intraventricular haemorrhage, nervous system disorder, refusal of treatment by patient. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX. Patient died on 10/10/2007.

Integrilin Side Effects Report #5584028-4
Pharmacist from UNITED STATES reported INTEGRILIN problem on Jan 04, 2008. Female patient, 53 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: face injury, fall, head injury, subarachnoid haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with ASPIRIN, LOVENOX, PLAVIX. Patient recovered.

Integrilin Side Effects Report #5603295-1
INTEGRILIN problem was reported by a Health Professional from CANADA on Jan 14, 2008. Male patient, 47 years of age, was diagnosed with percutaneous coronary intervention and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cerebral ischaemia, cerebrovascular accident, injection site haemorrhage, mouth haemorrhage, myocardial infarction, thrombocytopenia, thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with PLAVIX, ASPIRIN, HEPARIN. Patient was hospitalized and became disabled. Patient recovered.

Integrilin Side Effects Report #5545312-3
Pharmacist from UNITED STATES reported INTEGRILIN problem on Dec 05, 2007. Female patient, 68 years of age, weighting 233.7 lb, was diagnosed with thrombosis prophylaxis and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: ecchymosis, haematoma, thrombocytopenia. INTEGRILIN dosage: unknown. During the same period patient was treated with ASPIRIN, CLOPIDOGREL, HEPARIN, PREDNISONE, METHOTREXATE, FOLIC ACID, REMICADE, METOPROLOL. Patient recovered.

Integrilin Side Effects Report #5571837-0
INTEGRILIN problem was reported by a Physician from GERMANY on Dec 20, 2007. Male patient, 68 years of age, weighting 209.4 lb, was diagnosed with myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cerebellar haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with CLOPIDOGREL, HEPARIN, ASPIRIN. Patient died on 12/01/2007.

Integrilin Side Effects Report #5576549-5
Physician from GERMANY reported INTEGRILIN problem on Dec 27, 2007. Male patient, 68 years of age, weighting 209.4 lb, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cerebellar haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with CLOPIDOGREL, HEPARIN, ASPIRIN. Patient died on 12/11/2007.

Integrilin Side Effects Report #5507207-0
INTEGRILIN problem was reported by a Physician from UNITED STATES on Oct 23, 2007. Female patient, 57 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: catheter thrombosis, myocardial infarction. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX. Patient recovered.

Integrilin Side Effects Report #5502668-5
Pharmacist from UNITED STATES reported INTEGRILIN problem on Oct 19, 2007. Female patient was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, thrombocytopenia. INTEGRILIN dosage: unknown. During the same period patient was treated with HEPARIN. Patient recovered.

Integrilin Side Effects Report #5449479-7
INTEGRILIN problem was reported by a Physician from FRANCE on Aug 31, 2007. Female patient, 60 years of age, was diagnosed with myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, acute respiratory distress syndrome, pulmonary alveolar haemorrhage, pulmonary haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with KARDEGIC, HEPARIN, ATENOLOL, PLAVIX. Patient was hospitalized and became disabled. Patient recovered.

Integrilin Side Effects Report #5453440-6
Health Professional from UNITED STATES reported INTEGRILIN problem on Sept 05, 2007. Male patient, 70 years of age, weighting 238.1 lb, was diagnosed with catheterisation cardiac, percutaneous coronary intervention and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: arterial injury, cardiac procedure complication, coagulation time prolonged, condition aggravated. INTEGRILIN dosage: unknown. During the same period patient was treated with BIVALIRUDIN, HEPARIN. Patient recovered.

Integrilin Side Effects Report #5467688-8
INTEGRILIN problem was reported by a Physician from FRANCE on Sept 17, 2007. Male patient, 75 years of age, was diagnosed with acute coronary syndrome and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: dermatitis bullous, haemoptysis, petechiae, pyrexia, thrombocytopenia. INTEGRILIN dosage: 7 MG; ONCE; INBO; 12 ML; QH; INDRP. During the same period patient was treated with HEPARIN, LOVENOX, PLAVIX, ACETYLSALICYLATE LYSINE, NITRIDERM, SOTALEX, AMLOR, FINASTERIDE. Patient was hospitalized. Patient recovered.

Integrilin Side Effects Report #5407124-0
Consumer or non-health professional from CANADA reported INTEGRILIN problem on July 26, 2007. Male patient, 52 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cardiogenic shock, thrombocytopenia, ventricular tachycardia. INTEGRILIN dosage: unknown. During the same period patient was treated with ASPIRIN, CLOPIDOGREL, INSULIN, PROPOFOL, DIGOXIN, CARVEDILOL, ROCURONIUM BROMIDE, NITROGLYCERIN. Patient was hospitalized. Patient recovered.

Integrilin Side Effects Report #5412275-0
INTEGRILIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 10, 2007. Female patient, 61 years of age, was diagnosed with myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: haemoptysis. INTEGRILIN dosage: 9 MG/HR 18 HRS IV. During the same period patient was treated with HEPARIN, ASPIRIN, PLAVIX, ZANTAC, QUINAPRIL, COREG, ATORVASTATIN CALCIUM. Patient was hospitalized. Patient recovered.

Integrilin Side Effects Report #5420439-5
Physician from UNITED STATES reported INTEGRILIN problem on Aug 09, 2007. Female patient, 75 years of age, was diagnosed with myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: creatinine renal clearance decreased, overdose, peritoneal haemorrhage, post procedural haemorrhage, procedural complication. INTEGRILIN dosage: unknown. Patient died on 01/01/2007.

Integrilin Side Effects Report #5428936-3
INTEGRILIN problem was reported by a Physician from UNITED STATES on Aug 16, 2007. Female patient, 61 years of age, weighting 181.0 lb, was diagnosed with percutaneous coronary intervention and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, ventricular fibrillation, vomiting. INTEGRILIN dosage: 6 MG; ONCE; INBO, 13 ML; QH; INDRP. During the same period patient was treated with ANGIOMAX, ATROPINE, EPINEPHRINE, HEPARIN, ASPIRIN. Patient was hospitalized. Patient recovered.

Integrilin Side Effects Report #5382851-2
Pharmacist from UNITED STATES reported INTEGRILIN problem on June 28, 2007. Female patient, 62 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: procedural complication, thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX, PLAVIX. Patient recovered.

Integrilin Side Effects Report #5383642-9
INTEGRILIN problem was reported by a Pharmacist from UNITED STATES on June 28, 2007. Female patient, 52 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: procedural complication, thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX, HEPARIN. Patient recovered.

Integrilin Side Effects Report #5389122-9
Pharmacist from UNITED STATES reported INTEGRILIN problem on July 13, 2007. Female patient, 68 years of age, was diagnosed with coronary angioplasty, myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: heparin-induced thrombocytopenia, retroperitoneal haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX. Patient was hospitalized. Patient recovered.

Integrilin Side Effects Report #5389977-8
INTEGRILIN problem was reported by a Pharmacist from UNITED STATES on July 16, 2007. Female patient, 77 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, post procedural complication, pulmonary alveolar haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with VANCOMYCIN, LORAZEPAM, PLAVIX, POTASSIUM CHLORIDE, FUROSEMIDE, ALBUTEROL, HEPARIN. Patient died on 02/14/2006.

Integrilin Side Effects Report #5397793-6
Consumer or non-health professional from CANADA reported INTEGRILIN problem on July 17, 2007. Male patient, 47 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cerebral ischaemia, cerebrovascular accident, injection site haemorrhage, mouth haemorrhage, myocardial infarction, thrombocytopenia, thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with PLAVIX, ASPIRIN, HEPARIN. Patient recovered.

Integrilin Side Effects Report #5382851-2
INTEGRILIN problem was reported by a Pharmacist from UNITED STATES on June 28, 2007. Female patient, 62 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: procedural complication, thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX, PLAVIX. Patient recovered.

Integrilin Side Effects Report #5383642-9
Pharmacist from UNITED STATES reported INTEGRILIN problem on June 28, 2007. Female patient, 52 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: procedural complication, thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX, HEPARIN. Patient recovered.

Integrilin Side Effects Report #5389122-9
INTEGRILIN problem was reported by a Pharmacist from UNITED STATES on July 13, 2007. Female patient, 68 years of age, was diagnosed with coronary angioplasty, myocardial infarction and was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: heparin-induced thrombocytopenia, retroperitoneal haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with LOVENOX. Patient was hospitalized. Patient recovered.

Integrilin Side Effects Report #5389977-8
Pharmacist from UNITED STATES reported INTEGRILIN problem on July 16, 2007. Female patient, 77 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, post procedural complication, pulmonary alveolar haemorrhage. INTEGRILIN dosage: unknown. During the same period patient was treated with VANCOMYCIN, LORAZEPAM, PLAVIX, POTASSIUM CHLORIDE, FUROSEMIDE, ALBUTEROL, HEPARIN. Patient died on 02/14/2006.

Integrilin Side Effects Report #5397793-6
INTEGRILIN problem was reported by a Consumer or non-health professional from CANADA on July 17, 2007. Male patient, 47 years of age, was treated with INTEGRILIN. After drug was administered, patient experienced the following problems/side effects: cerebral ischaemia, cerebrovascular accident, injection site haemorrhage, mouth haemorrhage, myocardial infarction, thrombocytopenia, thrombosis. INTEGRILIN dosage: unknown. During the same period patient was treated with PLAVIX, ASPIRIN, HEPARIN. Patient recovered.


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paralysis, spinal cord haemorrhage, agitation, aortic arteriosclerosis, aortic valve incompetence, arteriosclerosis coronary artery, blood culture positive, bradycardia, brain herniation, bronchiolitis, cerebral arteriosclerosis, , was diagnosed with acute coronary syndrome and was diagnosed with stent placement, myocardial infarction and