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Angiomax (Bivalirudin) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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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