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Review Coumadin Safety Reports submitted to FDA

Total Coumadin reports: 216.
Coumadin FDA safety alerts: 2002 2005 2006 2007 .
Reported deaths: 64    Reported hospitalizations: 144.
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FDA Reported Coumadin Side Effects: international normalised ratio increased, international normalised ratio decreased, international normalised ratio fluctuation, death, international normalised ratio abnormal, epistaxis, fall, contusion, diarrhoea, dizziness, prothrombin time prolonged.
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Coumadin Side Effects Report #5385070-9
Pharmacist from UNITED STATES reported COUMADIN problem on July 06, 2007. Female patient, 82 years of age, weighting 167.6 lb, was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: haemoptysis, international normalised ratio increased, ventricular fibrillation. COUMADIN dosage: unknown. Patient died on 05/12/2006.

Coumadin Side Effects Report #5385326-X
COUMADIN problem was reported by a Pharmacist from UNITED STATES on July 09, 2007. Female patient, 67 years of age, weighting 196.2 lb, was diagnosed with thrombosis prophylaxis and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: ecchymosis, skin necrosis. COUMADIN dosage: 4 MG ONCE PO, 5 MG ONCE PO. Patient was hospitalized. Patient recovered.

Coumadin Side Effects Report #5385351-9
Pharmacist from UNITED STATES reported COUMADIN problem on July 09, 2007. Male patient, 78 years of age, weighting 262.4 lb, was diagnosed with atrial fibrillation and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, depressed level of consciousness, haemodialysis, metabolic acidosis, post procedural complication, renal failure, retroperitoneal haemorrhage, shock. COUMADIN dosage: 5 MG DAILY PO. During the same period patient was treated with HEPARIN, SINEMET, DILAUDID, PEPCID, PREVACID, ANZEMET, TYLENOL, REGLAN. Patient was hospitalized. Patient died on 05/10/2007.

Coumadin Side Effects Report #5386261-3
COUMADIN problem was reported by a Pharmacist from UNITED STATES on July 10, 2007. Female patient, weighting 170.0 lb, was diagnosed with pulmonary embolism and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: anaemia, cardiac arrest, haematoma, hypotension. COUMADIN dosage: 3MG DAILY PO. During the same period patient was treated with ZYVOX, PROTONIX, PRAVACHOL, TOPROL, SYNTHROID, CANASA SUPPOSITORY, DIGOXIN, ZOFRAN. Patient died on 02/15/2007.

Coumadin Side Effects Report #5386793-8
Consumer or non-health professional from UNITED STATES reported COUMADIN problem on July 10, 2007. Female patient, weighting 163.1 lb, was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, blood pressure increased, chest pain, international normalised ratio fluctuation, oedema peripheral, skin discolouration. COUMADIN dosage: unknown. During the same period patient was treated with LASIX, ASCORBIC ACID, TOPROL, MEVACOR, PROTONIX, COLACE. Patient recovered.

Coumadin Side Effects Report #5387057-9
COUMADIN problem was reported by a Consumer or non-health professional from UNITED STATES on July 09, 2007. Male patient, 81 years of age, was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: blue toe syndrome, disseminated intravascular coagulation, extremity necrosis, fat embolism, pneumonia, thrombosis. COUMADIN dosage: unknown. During the same period patient was treated with HEPARIN. Patient was hospitalized. Patient died.

Coumadin Side Effects Report #5389160-6
Physician from ITALY reported COUMADIN problem on July 16, 2007. Male patient, 88 years of age, was diagnosed with atrial fibrillation and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, abdominal pain upper. COUMADIN dosage: unknown. During the same period patient was treated with LASIX, QUARK, DELTACORTENE, MEPRAL, ALLOPURINOL, TRANQUIRIT, SERETIDE. Patient was hospitalized. Patient recovered.

Coumadin Side Effects Report #5390620-2
COUMADIN problem was reported by a Consumer or non-health professional from FRANCE on July 09, 2007. Male patient, 53 years of age, was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: international normalised ratio. COUMADIN dosage: unknown. During the same period patient was treated with PLAVIX, PLAQUENIL. Patient recovered.

Coumadin Side Effects Report #5394129-1
Physician from FRANCE reported COUMADIN problem on July 16, 2007. Female patient, 88 years of age, was diagnosed with atrial fibrillation, type 2 diabetes mellitus and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: hypoglycaemia. COUMADIN dosage: unknown. During the same period patient was treated with AMARYL, TRIATEC, ATORVASTATIN CALCIUM, KARDEGIC, FUROSEMIDE, POTASSIUM CHLORIDE, ARIMIDEX, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Coumadin Side Effects Report #5395540-5
COUMADIN problem was reported by a Health Professional from UNITED STATES on July 23, 2007. Male patient, 78 years of age, was diagnosed with deep vein thrombosis, atrial fibrillation, multiple myeloma and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, dehydration, epistaxis, gastrointestinal haemorrhage, haemorrhoidal haemorrhage, interstitial lung disease, malignant neoplasm progression, metabolic acidosis, prothrombin time prolonged. COUMADIN dosage: unknown. During the same period patient was treated with REVLIMID, DILTIAZEM, NORTRIPTYLINE, FUROSEMIDE, ASPIRIN, MS CONTIN, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient died on 04/02/2007.

Coumadin Side Effects Report #5396848-X
Physician from UNITED STATES reported COUMADIN problem on July 23, 2007. Female patient, 80 years of age, was diagnosed with deep vein thrombosis, myelodysplastic syndrome, hypertension and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: anaemia, coagulopathy, convulsion, gastrointestinal haemorrhage. COUMADIN dosage: unknown. During the same period patient was treated with REVLIMID, PHENYTOIN, LOVENOX, SYNTHROID, NORVASC, VITAMIN E. Patient recovered.

Coumadin Side Effects Report #5398997-9
COUMADIN problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2007. Male patient, 74 years of age, weighting 189.6 lb, was diagnosed with cardiac disorder and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: bronchitis, haemoptysis. COUMADIN dosage: unknown. During the same period patient was treated with FUROSEMIDE, METOPROLOL SUCCINATE, FINASTERIDE, SIMVASTATIN, TAMSULOSIN, ASPIRIN, POTASSIUM CHLORIDE, COMBIVENT. Patient was hospitalized. Patient recovered.

Coumadin Side Effects Report #5398999-2
Pharmacist from UNITED STATES reported COUMADIN problem on July 23, 2007. Female patient was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: cerebellar haemorrhage. COUMADIN dosage: 3 MG QD PO. Patient recovered.

Coumadin Side Effects Report #5399000-7
COUMADIN problem was reported by a Pharmacist from UNITED STATES on July 23, 2007. Female patient, 85 years of age, was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: international normalised ratio abnormal, subdural haematoma. COUMADIN dosage: 5MG QD PO. Patient died.

Coumadin Side Effects Report #5400042-3
Pharmacist from UNITED STATES reported COUMADIN problem on July 26, 2007. Female patient, 92 years of age, was diagnosed with atrial fibrillation and was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased. COUMADIN dosage: unknown. During the same period patient was treated with DIGOXIN, LASIX, POTASSIUM CHLORIDE, CELEXA, ATENOLOL. Patient was hospitalized. Patient recovered.

Coumadin Side Effects Report #5402299-1
COUMADIN problem was reported by a Physician from UNITED STATES on July 30, 2007. Female patient was treated with COUMADIN. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased. COUMADIN dosage: unknown. During the same period patient was treated with ZOMETA. Patient recovered.

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haemoptysis, international normalised ratio increased, ventricular fibrillation, ecchymosis, skin necrosis, , was diagnosed with thrombosis prophylaxis and was diagnosed with atrial fibrillation and was diagnosed with pulmonary embolism and