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Angiomax (Bivalirudin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Angiomax (Bivalirudin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (71)
Death (23)
Life Threatening Events (23)
Disability (3)

Reports by Reaction Type

Thrombosis in Device (18)Off Label Use (10)Coronary Artery Thrombosis (6)Acute Myocardial Infarction (6)Myocardial Infarction (6)Haemorrhage (5)Drug Ineffective (4)Coronary Artery Occlusion (4)Chest Pain (4)Procedural Complication (4)Hypersensitivity (3)Activated Partial Thromboplastin Time Prolonged (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Angiomax (Bivalirudin). For a complete list or a specific selection of reports, please use the links above.

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:
Brilinta
    Dosage: 180 mg loading dose
    Administration route: Oral
    Indication: Acute Myocardial Infarction
    Start date: 2012-08-10

Aspirin
    Administration route: Oral
    Indication: Acute Myocardial Infarction
    Start date: 2012-08-10
    End date: 2012-08-10

Angiomax
    Start date: 2012-08-10
    End date: 2012-08-10

Other drugs received by patient: Simvastatin; Isorbidmononitrat; Ramipril



Possible Angiomax side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient:

Reactions: Thrombosis in Device

Drug(s) suspected as cause:
Angiomax

Brilinta
    Administration route: Oral



Possible Angiomax side effects in

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient:

Reactions: Thrombosis in Device

Drug(s) suspected as cause:
Brilinta
    Administration route: Oral

Angiomax



Possible Angiomax side effects in female

Reported by a physician from Sweden on 2012-08-20

Patient: female

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Angiomax

Brilinta
    Administration route: Oral

Warfarin Sodium
    Administration route: Oral



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:
Brilinta
    Dosage: 180 mg loading dose
    Administration route: Oral
    Indication: Acute Myocardial Infarction
    Start date: 2012-08-10

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

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:
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

Adenosine
    Indication: Arterial Therapeutic Procedure
    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 male

Reported by a physician from United States on 2012-07-31

Patient: male

Reactions: Heart Rate Decreased, Hypersensitivity, Mouth Haemorrhage, Blood Pressure Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Angiomax



Possible Angiomax side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-30

Patient: 62 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Agitation, Haemorrhage Intracranial, Coma Scale Abnormal, Pupil Fixed, Acute Myocardial Infarction, Loss of Consciousness

Adverse event resulted in: death

Drug(s) suspected as cause:
Prasugrel (Prasugrel)
    Dosage: 600 mg, oral
    Administration route: Oral
    Start date: 2011-08-30
    End date: 2011-08-30

Aspirin
    Dosage: 75 mg, qd, oral
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2011-08-26
    End date: 2011-08-30

Enoxaparin Sodium
    Dosage: 60 mg, bid, subcutaneous
    Indication: Acute Coronary Syndrome
    Start date: 2011-08-26
    End date: 2011-08-30

Angiomax
    Dosage: 105 mg/hr, intravenous
    Start date: 2011-08-30
    End date: 2011-08-30

Clopidogrel
    Dosage: 75 mg, qd, oral
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2011-08-26
    End date: 2011-08-30

Other drugs received by patient: Beclomethasone Dipropionate; Albuterol Sulfate



Possible Angiomax side effects in 70 year old male

Reported by a physician from United States on 2012-07-24

Patient: 70 year old male

Reactions: Cardiogenic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Angiomax



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

Clopidogrel
    Dosage: unk
    Indication: Coronary Angioplasty
    End date: 2012-04-13

Aspirin
    Dosage: 100 mg
    Indication: Coronary Angioplasty
    End date: 2012-04-13



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 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 83 year old female

Reported by a physician from United States on 2012-07-11

Patient: 83 year old female

Reactions: Haemorrhage, Coronary Artery Occlusion, Thrombosis in Device

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Angiomax

Other drugs received by patient: Reopro; Aspirin; Prasugrel (Prasugrel)



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 53 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28

Patient: 53 year old male, weighing 104.5 kg (229.9 pounds)

Reactions: Coronary Artery Thrombosis

Drug(s) suspected as cause:
Angiomax
    Dosage: 16 ml, bolus, intravenous, 36.4 ml, hr, intravenous
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-05-01
    End date: 2012-05-01

Angiomax
    Dosage: 16 ml, bolus, intravenous, 36.4 ml, hr, intravenous
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-05-01
    End date: 2012-05-01

Other drugs received by patient: Prasugrel (Prasugrel); Aspirin



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

Heparin Sodium
    Dosage: 1800 iu
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-21
    End date: 2012-04-22

Angiomax
    Dosage: 0.75 ug/kg, bolus, intravenous bolus
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-04-23

Other drugs received by patient: Famotidine; Clopidegrel; Insulin; Atenolol; Fluoxetine; Fenofibrate



Possible Angiomax side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15

Patient: female

Reactions: Coronary Artery Occlusion, Coagulation Time Prolonged

Adverse event resulted in: death

Drug(s) suspected as cause:
Angiomax



Possible Angiomax side effects in

Reported by a physician from United States on 2012-06-14

Patient: , weighing 70.8 kg (155.8 pounds)

Reactions: Ventricular Tachycardia, Coagulation Time Prolonged

Drug(s) suspected as cause:
Angiomax



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 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 female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: female

Reactions: Platelet Function Test Abnormal

Drug(s) suspected as cause:
Effient
    Dosage: maintenance dose
    Indication: Coronary Revascularisation
    Start date: 2012-05-01

Reopro
    Indication: Vascular Operation
    Start date: 2012-05-01

Effient
    Dosage: maintenance dose
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-05-01

Effient
    Dosage: maintenance dose
    Start date: 2012-05-01

Effient
    Dosage: loading dose
    Start date: 2012-05-01

Effient
    Dosage: loading dose
    Indication: Acute Coronary Syndrome
    Start date: 2012-05-01

Angiomax
    Indication: Coronary Revascularisation
    Start date: 2012-05-01

Effient
    Dosage: loading dose
    Indication: Acute Myocardial Infarction
    Start date: 2012-05-01

Reopro
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-05-01

Effient
    Dosage: maintenance dose
    Start date: 2012-05-01

Effient
    Dosage: loading dose
    Start date: 2012-05-01

Heparin
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-05-01

Heparin
    Indication: Vascular Operation
    Start date: 2012-05-01

Angiomax
    Indication: Acute Myocardial Infarction
    Start date: 2012-05-01



Possible Angiomax side effects in male

Reported by a pharmacist from United States on 2012-05-23

Patient: male, weighing 77.0 kg (169.4 pounds)

Reactions: Pulmonary Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tnkase
    Indication: Acute Myocardial Infarction
    Start date: 2012-05-09

Angiomax
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-09

Plavix
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-09

Other drugs received by patient: Aspirin



Possible Angiomax side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-05-09

Patient: 74 year old male

Reactions: Monoplegia, Cerebral Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Indication: Percutaneous Coronary Intervention

Clopidogrel
    Indication: Percutaneous Coronary Intervention

Angiomax
    Indication: Percutaneous Coronary Intervention



Possible Angiomax side effects in 49 year old female

Reported by a physician from United States on 2012-05-08

Patient: 49 year old female, weighing 85.0 kg (187.0 pounds)

Reactions: Chest Pain, Coronary Artery Stenosis, Electrocardiogram ST Segment Elevation, Thrombosis in Device

Drug(s) suspected as cause:
Angiomax
    Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-03-09
    End date: 2012-03-09

Angiomax
    Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-03-09
    End date: 2012-03-09

Angiomax
    Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-03-09
    End date: 2012-03-09

Angiomax
    Dosage: 13 ml, bolus, intravenous 30 ml, hr, intravenous 13 ml, bolus, intravenous 30 ml, hr, intravenous
    Indication: Percutaneous Coronary Intervention
    Start date: 2012-03-09
    End date: 2012-03-09

Other drugs received by patient: Plavix; Isovue-370; Aspirin; Isovue-370



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 female

Reported by a physician from United States on 2012-05-01

Patient: female

Reactions: Coronary Artery Dissection, Procedural Complication, Thrombosis in Device

Drug(s) suspected as cause:
Angiomax



Possible Angiomax side effects in 73 year old female

Reported by a pharmacist from United States on 2012-05-01

Patient: 73 year old female

Reactions: Haemorrhage, Procedural Site Reaction, Blood Creatinine Increased

Drug(s) suspected as cause:
Angiomax

Angiomax
    Dosage: , intravenous
    Indication: Percutaneous Coronary Intervention



Possible Angiomax side effects in

Reported by a physician from United States on 2012-04-30

Patient:

Reactions: Off Label Use, Muscular Weakness, Haemorrhagic Stroke, Headache

Drug(s) suspected as cause:
Angiomax

Other drugs received by patient: Clopidogrel; Aspirin

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