Index of reports
> Life Threatening Events (23)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Angiomax (Bivalirudin) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Angiomax side effects in female
Reported by a physician from Sweden on 2012-08-24
Patient: female
Reactions: Cerebral Haematoma
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Angiomax
Start date: 2012-08-10
End date: 2012-08-10
Aspirin
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
End date: 2012-08-10
Brilinta
Dosage: 180 mg loading dose
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
Other drugs received by patient: Simvastatin; Isorbidmononitrat; Ramipril
Possible Angiomax side effects in female
Reported by a physician from Sweden on 2012-08-17
Patient: female
Reactions: Cerebral Haematoma
Adverse event resulted in: death, life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Angiomax
Start date: 2012-08-10
End date: 2012-08-10
Aspirin
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
End date: 2012-08-10
Brilinta
Dosage: 180 mg loading dose
Administration route: Oral
Indication: Acute Myocardial Infarction
Start date: 2012-08-10
Other drugs received by patient: Simvastatin; Ramipril; Isorbidmononitrat
Possible Angiomax side effects in 52 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08
Patient: 52 year old male, weighing 78.4 kg (172.5 pounds)
Reactions: Hypersensitivity, Respiratory Depression
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Adenosine
Indication: Arterial Therapeutic Procedure
Start date: 2012-08-01
End date: 2012-08-01
Angiomax
Dosage: 12 ml, bolus, intravenous, 28 ml/hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-08-01
End date: 2012-08-01
Angiomax
Dosage: 12 ml, bolus, intravenous, 28 ml/hr, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-08-01
Contrast Media
Start date: 2012-08-01
End date: 2012-08-01
Possible Angiomax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07
Patient: male
Reactions: Procedural Pain, Drug Ineffective, Pain, Coagulation Time Abnormal, Coronary NO-Reflow Phenomenon, Medication Error, Drug Administration Error, Vascular Access Complication, Infusion Site Extravasation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous, 1.75 mg/kg/hr, intravenous, bolus, intravenous
Indication: Coronary Angioplasty
Start date: 2012-07-25
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous, 1.75 mg/kg/hr, intravenous, bolus, intravenous
Indication: Coronary Angioplasty
Start date: 2012-07-25
Other drugs received by patient: Fentanyl; Versed; Heparin; Reopro
Possible Angiomax side effects in 73 year old male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-12
Patient: 73 year old male
Reactions: Subdural Haematoma, Hemiparesis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: 0.7 mg/kg, intravenous
Indication: Coronary Angioplasty
Start date: 2012-04-13
End date: 2012-04-13
Aspirin
Dosage: 100 mg
Indication: Coronary Angioplasty
End date: 2012-04-13
Clopidogrel
Dosage: unk
Indication: Coronary Angioplasty
End date: 2012-04-13
Possible Angiomax side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-11
Patient: male
Reactions: Tracheal Haemorrhage, Respiratory Arrest
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Angiomax
Indication: Percutaneous Coronary Intervention
Start date: 2012-04-17
End date: 2012-04-17
Reopro
Indication: Percutaneous Coronary Intervention
Start date: 2012-04-17
End date: 2012-04-17
Other drugs received by patient: Acetylsalicylic Acid SRT
Possible Angiomax side effects in 69 year old male
Reported by a physician from Italy on 2012-07-11
Patient: 69 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Product Quality Issue, Angina Pectoris, Drug Ineffective, Myocardial Infarction, Electrocardiogram ST Segment Elevation, Thrombosis in Device
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Other drugs received by patient: ASA (Asa); Hypoglycemic Oral Drug; Atorvastatin Calcium; Prasugrel (Prasugrel)
Possible Angiomax side effects in 63 year old female
Reported by a physician from Italy on 2012-07-11
Patient: 63 year old female, weighing 76.0 kg (167.2 pounds)
Reactions: Product Quality Issue, Vomiting, Drug Ineffective, Coronary Artery Stenosis, Incorrect Drug Administration Duration, Myocardial Infarction, Shock, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous;
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-20
End date: 2012-03-20
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous;
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-21
End date: 2012-03-21
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous;
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-20
End date: 2012-03-21
Other drugs received by patient: Heparin; ...; ...; Ticagrelor; Aspirin; Atorvastatin Calcium
Possible Angiomax side effects in 50 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21
Patient: 50 year old female
Reactions: Cardio-Respiratory Arrest, Haemorrhage, Coronary Artery Thrombosis, Heparin-Induced Thrombocytopenia, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: per hour, intravenous (not otherwise specified)
Start date: 2012-04-23
Angiomax
Dosage: 0.75 ug/kg, bolus, intravenous bolus
Indication: Percutaneous Coronary Intervention
Start date: 2012-04-23
Heparin Sodium
Dosage: 1800 iu
Indication: Product Used FOR Unknown Indication
Start date: 2012-04-21
End date: 2012-04-22
Other drugs received by patient: Famotidine; Clopidegrel; Insulin; Atenolol; Fluoxetine; Fenofibrate
Possible Angiomax side effects in 81 year old female
Reported by a physician from United States on 2012-06-14
Patient: 81 year old female, weighing 99.8 kg (219.6 pounds)
Reactions: Off Label Use, Cardiac Tamponade, Right Atrial Pressure Increased, Cardiac Perforation, Hypotension, Pericardial Haemorrhage
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Lasix; Cozaar; Sodium Chloride; Flovent (Fluiticasone Propionate); Calcium Plus D (Calcium, Colecalciferol); Versed; Fentanyl; Heparin; Aspirin; Florastor (Saccharomyces Boulardii); Nexium; Pravachol; Omeprazole; Fioricet with Codeine (Butalbital, Caffeine, Codeine Phosphate, Parace; Klor-CON; Betapace; Fish OIL; Systane (Macrogol, Propylene Glycol); Lidocaine; Ancef; Toprol-XL
Possible Angiomax side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-14
Patient: 59 year old female
Reactions: Coronary Artery Dissection, Procedural Complication, Acute Myocardial Infarction, Device Occlusion
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Effient
Possible Angiomax side effects in 50 year old female
Reported by a physician from United States on 2012-05-08
Patient: 50 year old female
Reactions: Cardio-Respiratory Arrest, Coronary Artery Thrombosis, Heparin-Induced Thrombocytopenia, Haemorrhage, Thrombocytopenia, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, intravenous; 1.75 mg/kg, hr
Indication: Percutaneous Coronary Intervention
Heparin
Dosage: 1800 iu
Start date: 2012-04-21
End date: 2012-04-22
Other drugs received by patient: Prozac; Clopidegrel; Insulin (Insulin); Atenolol; Famotidine; Fenofibrate
Possible Angiomax side effects in male
Reported by a physician from United States on 2012-05-01
Patient: male
Reactions: Cardio-Respiratory Arrest, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in 69 year old male
Reported by a physician from Italy on 2012-04-10
Patient: 69 year old male
Reactions: Myocardial Infarction, Thrombosis in Device
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Angiomax
Dosage: 0.75 mg/kg, bolus, intravenous 1.75 mg/kg, hr 0.25 mg/kg, hr for 75 minutes, intravenous
Indication: Percutaneous Coronary Intervention
Start date: 2012-03-27
End date: 2012-03-27
Other drugs received by patient: Atorvastatin Calcium; ASA (Asa); Prasugrel (Prasugrel)
Possible Angiomax side effects in 63 year old female
Reported by a physician from Italy on 2012-04-10
Patient: 63 year old female
Reactions: Vomiting, Myocardial Infarction, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Ticagrelor; ASA (Asa); Atorvastatin Calcium
Possible Angiomax side effects in female
Reported by a physician from United States on 2012-04-06
Patient: female, weighing 70.0 kg (154.0 pounds)
Reactions: Gastrointestinal Haemorrhage, Renal Failure, Hepatic Failure, Skin Haemorrhage, Acute Myocardial Infarction, Post Procedural Haemorrhage, Cardiac Arrest, Thrombosis in Device
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Angiomax
Aspirin
Dosage: 81 mg
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2009-01-01
End date: 2012-01-05
Plavix
Dosage: 75 mg
Administration route: Oral
Indication: Coronary Artery Disease
Start date: 2009-01-01
End date: 2012-01-05
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-05
End date: 2012-01-10
Reopro
Possible Angiomax side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-05
Patient: male
Reactions: Activated Partial Thromboplastin Time Prolonged, Coronary Artery Dissection, International Normalised Ratio Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Plavix
Possible Angiomax side effects in 87 year old female
Reported by a physician from United Kingdom on 2012-03-15
Patient: 87 year old female
Reactions: Cerebrovascular Accident
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in 82 year old female
Reported by a physician from United States on 2012-02-29
Patient: 82 year old female
Reactions: Ventricular Fibrillation, Resuscitation
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Angiomax
Possible Angiomax side effects in male
Reported by a pharmacist from United States on 2012-02-10
Patient: male, weighing 81.3 kg (178.9 pounds)
Reactions: Chest Pain, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Morphine; Ondansetron; Clopidogrel; Midazolam; Aspirin; Angiomax; Nitroglycerin 5mcg / MIN; Fentanyl Citrate; Iopamidol; Terazosin HCL; Heparin
Possible Angiomax side effects in female
Reported by a pharmacist from United States on 2012-02-10
Patient: female, weighing 112.0 kg (246.4 pounds)
Reactions: Product Quality Issue, Thrombosis in Device
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Metoclopramide; Fentanyl Citrate; Ondansetron; Morphine; Midazolam; Clopidogrel; Verapamil Extended-Release; Aspirin; Nitroglycerin; Heparin
Possible Angiomax side effects in 69 year old female
Reported by a physician from United States on 2012-02-06
Patient: 69 year old female
Reactions: Vomiting, Reperfusion Injury, Haemorrhage, Nausea, Pulmonary Thrombosis, Coagulation Time Prolonged
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Angiomax
Indication: Acute Myocardial Infarction
Heparin
Indication: Acute Myocardial Infarction
Possible Angiomax side effects in
Reported by a physician from United States on 2011-10-18
Patient:
Reactions: Retroperitoneal Haematoma, Vessel Perforation, Cardiac Arrest
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Angiomax
Other drugs received by patient: Reopro; Plavix
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