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Review Fondaparinux Safety Reports submitted to FDA

Total Fondaparinux reports: 16.
Fondaparinux FDA safety alerts: No.
Reported deaths: 5    Reported hospitalizations: 7.
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FDA Reported Fondaparinux Side Effects: haematocrit decreased, haemoglobin decreased, intra-abdominal haemorrhage, gastritis, purpura, pain, ecchymosis, creatinine renal clearance decreased, blood creatinine increased, wound haemorrhage, incorrect dose administered.
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Fondaparinux Side Effects Report #5636060-X
Physician from UNITED STATES reported FONDAPARINUX problem on Feb 20, 2008. Female patient, 41 years of age, was diagnosed with thrombosis prophylaxis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: embolism, poor peripheral circulation, thrombosis. FONDAPARINUX dosage: 7.5 MG DAILY SQ. Patient died.

Fondaparinux Side Effects Report #5644175-5
FONDAPARINUX problem was reported by a Physician from UNITED STATES on Feb 27, 2008. Male patient, 74 years of age, was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: post procedural haematoma, post procedural haemorrhage. FONDAPARINUX dosage: 2.5 MG EVERY DAY SQ. Patient was hospitalized. Patient recovered.

Fondaparinux Side Effects Report #5591399-1
Pharmacist from UNITED STATES reported FONDAPARINUX problem on Jan 11, 2008. Male patient, 58 years of age, weighting 113.5 lb, was diagnosed with thrombosis prophylaxis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: cardio-respiratory arrest, depressed level of consciousness, haemorrhage intracranial. FONDAPARINUX dosage: 2.5MG EVERY 24 HOURS SQ. Patient died on 01/08/2008.

Fondaparinux Side Effects Report #5551112-0
FONDAPARINUX problem was reported by a Physician from FRANCE on Dec 03, 2007. Female patient, 82 years of age, weighting 143.3 lb, was diagnosed with anxiety and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: anaemia, angina pectoris, electrocardiogram st segment depression. FONDAPARINUX dosage: 1.5MG PER DAY. During the same period patient was treated with LASIX, ZESTRIL, KARDEGIC, AMLOR, AMARYL, VASTAREL, LEXOMIL, CONTRAMAL. Patient was hospitalized. Patient recovered.

Fondaparinux Side Effects Report #5551126-0
Physician from FRANCE reported FONDAPARINUX problem on Dec 03, 2007. Male patient, 79 years of age, weighting 149.9 lb, was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: balance disorder, malaise. FONDAPARINUX dosage: 1.5MG PER DAY. Patient was hospitalized and became disabled. Patient recovered.

Fondaparinux Side Effects Report #5568136-X
FONDAPARINUX problem was reported by a Pharmacist from UNITED STATES on Dec 18, 2007. Male patient, 86 years of age, was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: haematuria. FONDAPARINUX dosage: 2.5MG EVERY DAY SQ. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.

Fondaparinux Side Effects Report #5530484-7
Pharmacist from UNITED STATES reported FONDAPARINUX problem on Nov 27, 2007. Male patient, 80 years of age, was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: haemorrhage. FONDAPARINUX dosage: 2.5MG EVERY DAY PO. Patient recovered.

Fondaparinux Side Effects Report #5477671-4
FONDAPARINUX problem was reported by a Pharmacist from UNITED STATES on Oct 01, 2007. Male patient, 62 years of age, was diagnosed with budd-chiari syndrome, pulmonary embolism and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: asthenia, fall, subdural haematoma, surgical procedure repeated. FONDAPARINUX dosage: unknown. During the same period patient was treated with FONDAPARINUX GLAXOSMITHKLINE, URSO, FLOMAX, MEPRON, DYAZIDE, AMOXICILLIN, VALTREX, AMBIEN. Patient was hospitalized. Patient recovered.

Fondaparinux Side Effects Report #5392101-9
Physician from UNITED STATES reported FONDAPARINUX problem on July 18, 2007. Female patient, weighting 158.7 lb, was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: intra-abdominal haemorrhage. FONDAPARINUX dosage: 7.5 MG DAILY SQ. Patient died on 07/03/2007.

Fondaparinux Side Effects Report #5392127-5
FONDAPARINUX problem was reported by a Physician from UNITED STATES on July 18, 2007. Male patient, 84 years of age, weighting 163.1 lb, was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, creatinine renal clearance decreased, ecchymosis, pain, purpura. FONDAPARINUX dosage: 7.5 MG DAILY SQ. Patient recovered.

Fondaparinux Side Effects Report #5392128-7
Physician from UNITED STATES reported FONDAPARINUX problem on July 18, 2007. Female patient, 88 years of age, weighting 158.7 lb, was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: intra-abdominal haemorrhage. FONDAPARINUX dosage: 7.5 MG DAILY SQ. Patient died on 07/03/2007.

Fondaparinux Side Effects Report #5393367-1
FONDAPARINUX problem was reported by a Physician from UNITED STATES on July 18, 2007. Male patient was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: gastritis. FONDAPARINUX dosage: 7.5MG DAILY SQ. Patient was hospitalized. Patient recovered.

Fondaparinux Side Effects Report #5392101-9
Physician from UNITED STATES reported FONDAPARINUX problem on July 18, 2007. Female patient, weighting 158.7 lb, was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: intra-abdominal haemorrhage. FONDAPARINUX dosage: 7.5 MG DAILY SQ. Patient died on 07/03/2007.

Fondaparinux Side Effects Report #5392127-5
FONDAPARINUX problem was reported by a Physician from UNITED STATES on July 18, 2007. Male patient, 84 years of age, weighting 163.1 lb, was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, creatinine renal clearance decreased, ecchymosis, pain, purpura. FONDAPARINUX dosage: 7.5 MG DAILY SQ. Patient recovered.

Fondaparinux Side Effects Report #5392128-7
Physician from UNITED STATES reported FONDAPARINUX problem on July 18, 2007. Female patient, 88 years of age, weighting 158.7 lb, was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: intra-abdominal haemorrhage. FONDAPARINUX dosage: 7.5 MG DAILY SQ. Patient died on 07/03/2007.

Fondaparinux Side Effects Report #5393367-1
FONDAPARINUX problem was reported by a Physician from UNITED STATES on July 18, 2007. Male patient was diagnosed with deep vein thrombosis and was treated with FONDAPARINUX. After drug was administered, patient experienced the following problems/side effects: gastritis. FONDAPARINUX dosage: 7.5MG DAILY SQ. Patient was hospitalized. Patient recovered.


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embolism, poor peripheral circulation, thrombosis, post procedural haematoma, post procedural haemorrhage, , was diagnosed with thrombosis prophylaxis and was diagnosed with thrombosis prophylaxis and was diagnosed with anxiety and