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Bivalirudin Safety Reports submitted to FDA

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Total Bivalirudin reports: 8.
Bivalirudin FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Bivalirudin Side Effects: diabetic neuropathy, asthenia, angina unstable, hypotension, resuscitation, intracardiac thrombus, cardiogenic shock, retroperitoneal haematoma, medical device complication, haematocrit decreased, complication of device insertion.
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Bivalirudin Side Effects Report #5206909-3
Consumer or non-health professional from UNITED STATES reported BIVALIRUDIN problem on Jan 05, 2007. Female patient, 70 years of age, weighting 141.5 lb, was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: hypotension, infusion related reaction, loss of consciousness, thrombosis. BIVALIRUDIN dosage: 12.75MG IV X 1; 29.75MG/HR. During the same period patient was treated with AMIODARONE, ENALAPRIL MALEATE, HYDROMORPHONE, LORAZEPAM, ACETYLCYSTEINE. Patient recovered.

Bivalirudin Side Effects Report #5212963-5
BIVALIRUDIN problem was reported by a Health Professional from UNITED STATES on Jan 17, 2007. Male patient, weighting 180.0 lb, was diagnosed with arterial therapeutic procedure and was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. BIVALIRUDIN dosage: unknown. During the same period patient was treated with PLAVIX. Patient recovered.

Bivalirudin Side Effects Report #5310291-0
Physician from UNITED STATES reported BIVALIRUDIN problem on Apr 17, 2007. Male patient, 75 years of age, weighting 191.8 lb, was diagnosed with percutaneous coronary intervention and was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: bradycardia. BIVALIRUDIN dosage: unknown. During the same period patient was treated with PLAVIX, FENTANYL, MIDAZOLAM. Patient recovered.

Bivalirudin Side Effects Report #5065181-8
BIVALIRUDIN problem was reported by a Health Professional from UNITED STATES on Aug 19, 2005. Female patient, 78 years of age, weighting 138.9 lb, was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: hypotension. BIVALIRUDIN dosage: unknown. During the same period patient was treated with MIDAZOLAM, ASPIRIN, PLAVIX, LASIX, POTASSIUM, DARVOCET. Patient recovered.

Bivalirudin Side Effects Report #5084461-3
Health Professional from UNITED STATES reported BIVALIRUDIN problem on Aug 02, 2006. Female patient, 67 years of age, was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: angina unstable, asthenia, bacteria urine, blood urine, diabetic complication, diabetic neuropathy, electrocardiogram st segment elevation, fall, fatigue. BIVALIRUDIN dosage: 75 + 175 MG, BOLUS, IV BOLUS - SEE IMAGE. During the same period patient was treated with ASPIRIN, PLAVIX, CARDURA, INSULIN, LOPRESSOR, NORVASC. Patient was hospitalized. Patient recovered.

Bivalirudin Side Effects Report #5093603-5
BIVALIRUDIN problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 15, 2006. Female patient, 67 years of age, weighting 224.9 lb, was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, angina unstable, asthenia, balance disorder, blood creatine phosphokinase increased, blood glucose decreased, chills, diabetic end stage renal disease, diabetic neuropathy. BIVALIRUDIN dosage: 75 MG, BOLUS, IV BOLUS 175 MG, HR. During the same period patient was treated with ASPIRIN, PLAVIX, CARDURA, HUMULIN R, LOPRESSOR, NORVASC, ZOCOR. Patient was hospitalized. Patient recovered.

Bivalirudin Side Effects Report #5195631-8
Health Professional from UNITED STATES reported BIVALIRUDIN problem on Dec 22, 2006. Male patient, weighting 210.0 lb, was diagnosed with percutaneous coronary intervention, platelet aggregation inhibition and was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: arterial disorder, complication of device insertion, haematocrit decreased, medical device complication, retroperitoneal haematoma. BIVALIRUDIN dosage: unknown. During the same period patient was treated with INTEGRILIN. Patient was hospitalized. Patient recovered.

Bivalirudin Side Effects Report #5378106-2
BIVALIRUDIN problem was reported by a Pharmacist from UNITED STATES on July 02, 2007. Female patient, 61 years of age, weighting 180.8 lb, was treated with BIVALIRUDIN. After drug was administered, patient experienced the following problems/side effects: cardiogenic shock, intracardiac thrombus, resuscitation. BIVALIRUDIN dosage: unknown. Patient recovered.

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