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Tnkase (Tenecteplase) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tnkase (Tenecteplase) 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 (8)
Death (5)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Haemorrhage Intracranial (3)Death (2)Haemorrhage (1)Myocardial Ischaemia (1)Wrong Drug Administered (1)Headache (1)Hemiparesis (1)Wound Secretion (1)Brain Injury (1)Overdose (1)Cold Sweat (1)Acute Myocardial Infarction (1)

Possible Tnkase side effects in

Reported by a individual with unspecified qualification from Canada on 2012-07-30

Patient:

Reactions: Haemorrhage, Myocardial Ischaemia, Haemorrhage Intracranial, Catheter Site Haemorrhage, Cardiogenic Shock, Death, Cardiac Failure, Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Clopidogrel
    Dosage: 300 mg, unk
    Indication: Acute Myocardial Infarction

Clopidogrel
    Dosage: 75 mg, unk

Tnkase
    Dosage: unk
    Indication: Acute Myocardial Infarction

GP IIB / Iiia Inhibitor (Study Drug)
    Dosage: unk
    Indication: Acute Myocardial Infarction

Aspirin
    Dosage: unk
    Indication: Acute Myocardial Infarction

Heparin
    Dosage: unk
    Indication: Acute Myocardial Infarction



Possible Tnkase side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20

Patient: 60 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Haemorrhagic Transformation Stroke

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tnkase



Possible Tnkase side effects in 83 year old female

Reported by a pharmacist from Canada on 2012-07-20

Patient: 83 year old female, weighing 49.9 kg (109.9 pounds)

Reactions: Thrombolysis, Acute Myocardial Infarction, Cerebral Haematoma

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tnkase

Other drugs received by patient: Lovenox; Plavix; Aspirin



Possible Tnkase 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 Tnkase side effects in 45 year old female

Reported by a pharmacist from Canada on 2012-05-17

Patient: 45 year old female

Reactions: Brain Injury, Haemorrhage Intracranial, Brain Scan Abnormal

Adverse event resulted in: death

Drug(s) suspected as cause:
Tnkase

Other drugs received by patient: Insulin; Norepinephrine Bitartrate; Dopamine HCL; Sodium Bicarbonate; Heparin Sodium; Ranitidine



Possible Tnkase side effects in 80 year old female

Reported by a pharmacist from United States on 2012-02-21

Patient: 80 year old female, weighing 63.9 kg (140.6 pounds)

Reactions: Haemorrhage Intracranial, Headache, Hemiparesis, Wound Secretion, Haemoglobin Decreased, Pulse Absent, Platelet Count Decreased, Cold Sweat, Haematoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Tnkase
    Dosage: 0.15-0.3 mg/hr continuous directed catherter thrombolysis
    Indication: Vascular Graft Occlusion
    Start date: 2012-02-01
    End date: 2012-02-04

Tnkase
    Dosage: 0.15-0.3 mg/hr continuous directed catherter thrombolysis
    Indication: Peripheral Vascular Disorder
    Start date: 2012-02-01
    End date: 2012-02-04

Other drugs received by patient: Cryoprecipitated AHF; Amlodipine; RED Blood Cells; Metoprolol Succinate; Fresh Frozen Plasma



Possible Tnkase side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-19

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tnkase



Possible Tnkase side effects in 50 year old female

Reported by a pharmacist from United States on 2011-11-28

Patient: 50 year old female, weighing 100.0 kg (220.0 pounds)

Reactions: NO Adverse Event, Overdose, Wrong Drug Administered

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tnkase

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