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Novoseven (Coagulation Factor VIIA) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Novoseven (Coagulation Factor VIIA) 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 (66)
Death (28)
Life Threatening Events (7)

Reports by Reaction Type

Haemorrhage (8)Death (8)Deep Vein Thrombosis (8)Troponin I Increased (6)Multi-Organ Failure (5)Cerebral Infarction (5)Abdominal Pain (4)Drug Ineffective (4)Disseminated Intravascular Coagulation (3)Device Related Infection (3)Bone Pain (2)Foetal Exposure During Pregnancy (2)

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

Possible Novoseven side effects in 77 year old male

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

Patient: 77 year old male

Reactions: Ischaemic Stroke, Sensorimotor Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novoseven
    Dosage: 5 mg, qd

Novoseven
    Dosage: 2 mg/iv

Novoseven
    Dosage: 5 mg, qd
    Indication: Product Used FOR Unknown Indication

Novoseven
    Dosage: 1 mg, qd

Other drugs received by patient: Nexium; Wilfactin; Prednisone TAB; Metformin HCL; Nicardipine HCL; Chondrosulf; Lovenox; Crestor; Fenofibrate Biogaran; Aspirin



Possible Novoseven side effects in 13 year old male

Reported by a physician from Germany on 2012-08-14

Patient: 13 year old male, weighing 47.3 kg (104.1 pounds)

Reactions: Back Pain, Abdominal Pain, Vomiting, Haematuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novoseven
    Dosage: 8+5mg every second day
    Indication: Factor Viii Deficiency
    Start date: 2008-01-01

Novoseven
    Dosage: 8+5mg every second day

Other drugs received by patient: Ibuprofen



Possible Novoseven side effects in female

Reported by a physician from United States on 2012-08-10

Patient: female, weighing 72.8 kg (160.2 pounds)

Reactions: Mitral Valve Disease, Mass, Tricuspid Valve Disease, Embolic Stroke, Bradycardia, Cardiac Arrest, Pulseless Electrical Activity

Adverse event resulted in: death

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: male, weighing 36.4 kg (80.0 pounds)

Reactions: Device Related Infection

Drug(s) suspected as cause:
Advate
    Dosage: 1639 units
    Start date: 2004-01-01

Novoseven

Advate
    Start date: 2004-02-01
    End date: 2004-02-01

Advate
    Indication: Factor Viii Inhibition
    Start date: 2004-02-01



Possible Novoseven side effects in male

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

Patient: male

Reactions: Abdominal Pain, Haemorrhage, Pallor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novoseven
    Start date: 2012-06-01
    End date: 2012-06-27

Feiba
    Dosage: 3000 ue per day
    Start date: 2012-06-01

Feiba
    Dosage: 3000 ue per day
    Start date: 2012-07-04

Feiba
    Dosage: 3000 ue per day
    Start date: 2012-07-03



Possible Novoseven side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: male, weighing 36.4 kg (80.0 pounds)

Reactions: Device Related Infection

Drug(s) suspected as cause:
Advate
    Indication: Factor Viii Inhibition
    Start date: 2004-02-01

Advate
    Start date: 2004-02-01
    End date: 2004-02-01

Novoseven

Advate
    Dosage: 1639 units
    Start date: 2004-01-01



Possible Novoseven side effects in male

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-07-13

Patient: male

Reactions: Abdominal Pain, Haemorrhage, Pallor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Feiba 1000 U, Poudre ET Solvant Pour Solution Injectable
    Dosage: 3000 ue per day
    Start date: 2012-07-03

Novoseven



Possible Novoseven side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: male, weighing 36.4 kg (80.0 pounds)

Reactions: Device Related Infection, Factor Viii Inhibition

Drug(s) suspected as cause:
Novoseven

Advate
    Dosage: 1639 units
    Start date: 2004-01-01

Advate
    Start date: 2004-02-01
    End date: 2004-02-01

Advate
    Indication: Factor Viii Inhibition
    Start date: 2004-02-01



Possible Novoseven side effects in 13 year old male

Reported by a physician from Germany on 2012-07-09

Patient: 13 year old male, weighing 47.3 kg (104.1 pounds)

Reactions: Abdominal Pain, Back Pain, Vomiting, Haematuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novoseven
    Dosage: 13 mg, unk

Novoseven
    Dosage: 13 mg, unk
    Indication: Factor Viii Deficiency
    Start date: 2008-01-01

Other drugs received by patient: Ibuprofen



Possible Novoseven side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-09

Patient: 60 year old male

Reactions: Multi-Organ Failure, Left Ventricular Dysfunction, Haemorrhage, Disseminated Intravascular Coagulation, Aortic Thrombosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Novoseven
    Dosage: 90 ug
    Indication: Product Used FOR Unknown Indication

Clopidogrel
    Indication: Arterial Stenosis



Possible Novoseven side effects in 70 year old male

Reported by a physician from Switzerland on 2012-06-26

Patient: 70 year old male, weighing 69.0 kg (151.8 pounds)

Reactions: Cerebral Ischaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Novoseven
    Dosage: 31 mg, qd
    Indication: Factor Viii Deficiency
    Start date: 2012-05-23

Cyklokapron
    Dosage: 2.5 g, qd
    Administration route: Oral
    Start date: 2012-05-27

Cyklokapron
    Dosage: 1.5 g, qd
    Administration route: Oral
    Start date: 2012-05-28
    End date: 2012-06-01

Novoseven
    Dosage: 40 mg, qd
    Start date: 2012-05-24

Cyklokapron
    Dosage: 1 g, tid
    Administration route: Oral
    Indication: Haemorrhage
    Start date: 2012-05-22
    End date: 2012-05-26

Novoseven
    Dosage: 19 mg, qd
    Indication: Gastrointestinal Haemorrhage
    Start date: 2012-05-22

Novoseven
    Dosage: 21 mg, qd
    Start date: 2012-05-25



Possible Novoseven side effects in 48 year old male

Reported by a physician from Italy on 2012-06-22

Patient: 48 year old male, weighing 150.0 kg (330.0 pounds)

Reactions: Troponin I Increased

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in 74 year old female

Reported by a physician from Italy on 2012-06-22

Patient: 74 year old female

Reactions: Troponin I Increased, Deep Vein Thrombosis

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in 68 year old male

Reported by a physician from Italy on 2012-06-22

Patient: 68 year old male, weighing 100.0 kg (220.0 pounds)

Reactions: Cerebral Infarction, Troponin I Increased, Deep Vein Thrombosis

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-19

Patient: 31 year old female

Reactions: Dialysis, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Bupivacaine Aguettant
    Dosage: 10 mg, qd
    Indication: Spinal Anaesthesia
    Start date: 2012-01-08
    End date: 2012-01-08

Cefazolin
    Dosage: once daily
    Indication: Antibiotic Prophylaxis
    Start date: 2012-01-08
    End date: 2012-01-08

Clottafact
    Dosage: 6 g, qd
    Indication: Third Stage Postpartum Haemorrhage
    Start date: 2012-01-08
    End date: 2012-01-08

Sevoflurane
    Dosage: unk
    Indication: Anaesthesia
    Start date: 2012-01-08
    End date: 2012-01-08

Novoseven
    Dosage: 4 mg, qd
    Indication: Third Stage Postpartum Haemorrhage
    Start date: 2012-01-08
    End date: 2012-01-08

Ephedrine
    Dosage: 60 mg, qd
    Indication: Spinal Anaesthesia
    Start date: 2012-01-08
    End date: 2012-01-08

Tagamet
    Dosage: 400 mg, qd
    Indication: Spinal Anaesthesia
    Start date: 2012-01-08
    End date: 2012-01-08

Pabal
    Dosage: 100 a?g, qd
    Indication: Uterine Atony
    Start date: 2012-01-08
    End date: 2012-01-08

Nalador
    Dosage: 1000 a?g, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-08
    End date: 2012-01-08

Omeprazole
    Dosage: 4 g, qd
    Indication: Postpartum Haemorrhage
    Start date: 2012-01-08
    End date: 2012-01-08

Other drugs received by patient: Platelets, Concentrated; RED Blood Cells; Celocurine / 00057702 /; Diprivan; Phenylephrine HCL; Voluven; Fresh Frozen Plasma; Tracrium



Possible Novoseven side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-07

Patient: 31 year old female

Reactions: Dialysis, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Novoseven
    Dosage: 4 mg, qd
    Indication: Third Stage Postpartum Haemorrhage
    Start date: 2012-01-08
    End date: 2012-01-08

Cefazolin
    Dosage: once daily
    Indication: Antibiotic Prophylaxis
    Start date: 2012-01-08
    End date: 2012-01-08

Ephedrine
    Dosage: 60 mg, qd
    Indication: Spinal Anaesthesia
    Start date: 2012-01-08
    End date: 2012-01-08

Omeprazole
    Dosage: 4 g, qd
    Indication: Postpartum Haemorrhage
    Start date: 2012-01-08
    End date: 2012-01-08

Tagamet
    Dosage: 400 mg, qd
    Indication: Spinal Anaesthesia
    Start date: 2012-01-08
    End date: 2012-01-08

Marcaine HCL
    Dosage: 10 mg, qd
    Indication: Spinal Anaesthesia

Sevoflurane
    Dosage: unk
    Indication: Anaesthesia
    Start date: 2012-01-08
    End date: 2012-01-08

Clottafact
    Dosage: 6 g, qd
    Indication: Third Stage Postpartum Haemorrhage
    Start date: 2012-01-08
    End date: 2012-01-08

Nalador
    Dosage: 1000 a?g, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-08
    End date: 2012-01-08

Pabal
    Dosage: 100 a?g, qd
    Indication: Uterine Atony
    Start date: 2012-01-08
    End date: 2012-01-08

Other drugs received by patient: Celocurine / 00057702 /; Tracrium; Phenylephrine HCL; Fresh Frozen Plasma; Diprivan; RED Blood Cells; Voluven; Platelets, Concentrated



Possible Novoseven side effects in 60 year old male

Reported by a individual with unspecified qualification from France on 2012-05-31

Patient: 60 year old male

Reactions: Multi-Organ Failure, Left Ventricular Dysfunction, Postoperative Thrombosis, Haemorrhage, Disseminated Intravascular Coagulation, Aortic Thrombosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Novoseven
    Dosage: 90 ug/kg
    Indication: Product Used FOR Unknown Indication

Clopidegrel
    Indication: Arterial Stenosis



Possible Novoseven side effects in 67 year old female

Reported by a physician from United States on 2012-05-02

Patient: 67 year old female, weighing 53.1 kg (116.8 pounds)

Reactions: Brain Death, Platelet Aggregation, Brain Herniation, Tachycardia, Unresponsive To Stimuli, Cerebellar Infarction, Cerebral Infarction, Cerebral Thrombosis, Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Novoseven

Other drugs received by patient: Vasopressin; Aminocaproic Acid; Epsilon



Possible Novoseven side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-01

Patient: male

Reactions: Post Procedural Haemorrhage

Drug(s) suspected as cause:
Feiba

Novoseven

Feiba



Possible Novoseven side effects in 46 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-26

Patient: 46 year old male

Reactions: Deep Vein Thrombosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Novoseven
    Dosage: 4 mg, qid
    Start date: 2011-09-04
    End date: 2011-09-04

Novoseven
    Dosage: 5 mg, tid
    Start date: 2011-08-31
    End date: 2011-08-31

Novoseven
    Dosage: 5 mg, qid
    Start date: 2011-09-02
    End date: 2011-09-02

Novoseven
    Dosage: 2 mg, tid
    Start date: 2011-08-30
    End date: 2011-08-30

Novoseven
    Dosage: 5 mg qd then 4 mg tid
    Start date: 2011-09-03
    End date: 2011-09-03

Novoseven
    Dosage: 4 mg qid and 5 mg qd
    Start date: 2011-09-05
    End date: 2011-09-05

Novoseven
    Dosage: 5 mg,qd
    Indication: Shock Haemorrhagic
    Start date: 2011-08-29
    End date: 2011-08-29

Novoseven
    Dosage: 5 mg, tid
    Start date: 2011-09-01
    End date: 2011-09-01

Novoseven
    Dosage: 5 mg, qid
    Start date: 2011-09-06
    End date: 2011-09-06

Other drugs received by patient: Omeprazole



Possible Novoseven side effects in 48 year old male

Reported by a physician from Italy on 2012-04-26

Patient: 48 year old male, weighing 150.0 kg (330.0 pounds)

Reactions: Troponin I Increased

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in

Reported by a physician from United States on 2012-04-26

Patient:

Reactions: Post Procedural Haemorrhage

Drug(s) suspected as cause:
Feiba

Novoseven



Possible Novoseven side effects in 68 year old male

Reported by a physician from Italy on 2012-04-19

Patient: 68 year old male, weighing 100.0 kg (220.0 pounds)

Reactions: Cerebral Infarction, Troponin I Increased, Deep Vein Thrombosis

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in 74 year old female

Reported by a physician from Italy on 2012-04-19

Patient: 74 year old female

Reactions: Troponin I Increased, Deep Vein Thrombosis

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-16

Patient: 54 year old male

Reactions: Atrioventricular Block Complete, Myocardial Ischaemia, Bradycardia, Cardiogenic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Novoseven

Other drugs received by patient: Dobutamine HCL



Possible Novoseven side effects in 64 year old male

Reported by a physician from Israel on 2012-04-16

Patient: 64 year old male

Reactions: Multi-Organ Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in 46 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-05

Patient: 46 year old male

Reactions: Deep Vein Thrombosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Novoseven

Other drugs received by patient: Omeprazole



Possible Novoseven side effects in male

Reported by a physician from Germany on 2012-04-04

Patient: male

Reactions: Renal Haemorrhage, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novoseven



Possible Novoseven side effects in 90 year old female

Reported by a physician from Japan on 2012-04-02

Patient: 90 year old female, weighing 43.0 kg (94.6 pounds)

Reactions: Death, Drug Ineffective

Adverse event resulted in: death

Drug(s) suspected as cause:
Novoseven

Other drugs received by patient: Fresh Frozen Plasma



Possible Novoseven side effects in 30 year old female

Reported by a physician from France on 2012-03-22

Patient: 30 year old female, weighing 86.0 kg (189.2 pounds)

Reactions: Overdose, Maternal Exposure During Pregnancy, Pulmonary Embolism, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Novoseven

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