Novoseven (Coagulation Factor Viia (Recombinant, Human)) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

NovoSeven has been generally well tolerated in clinical studies in 298 patients with hemophilia A or B with inhibitors treated for 1,939 bleeding episodes. The table below lists adverse events that were reported in >/=2% of NovoSeven patients and were considered to be at least possibly related or of unknown relationship to NovoSeven administration.

Events which were reported in 1% of patients and were considered to be at least possibly or of unknown relationship to NovoSeven administration were: allergic reaction, arthrosis, bradycardia, coagulation disorder, DIC, edema, fibrinolysis increased, headache, hypotension, injection site reaction, pain, pneumonia, prothrombin decreased, pruritus, purpura, rash, renal function abnormal, therapeutic response decreased, and vomiting.

In the 298 hemophilia patients, thrombosis was reported in two patients.

Serious adverse events that were probably or possibly related, or where the relationship to NovoSeven was not specified occurred in 14 of the 298 patients (4.7%). Six of these 14 patients died of the following conditions: worsening of chronic renal failure, anesthesia complications during proctoscopy, renal failure complicating a retroperitoneal bleed, ruptured abscess leading to sepsis and DIC, pneumonia, and splenic hematoma and GI bleeding.

REPORTS OF SUSPECTED NOVOSEVEN SIDE EFFECTS / ADVERSE REACTIONS

Possible Novoseven side effects / adverse reactions in 75 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2011-10-11

Patient: 75 year old male weighing 61.0 kg (134.2 pounds)

Reactions: Drug Ineffective

Adverse event resulted in: hospitalization

Suspect drug(s):
Feiba
    Start date: 2011-08-10
    End date: 2011-08-16

Novoseven
    Indication: Haemorrhage

Feiba
    Start date: 2011-08-10
    End date: 2011-08-16

Feiba
    Indication: Haemorrhage
    Start date: 2011-08-05
    End date: 2011-08-09

Feiba
    Indication: Acquired Haemophilia
    Start date: 2011-08-05
    End date: 2011-08-09

Novoseven
    Indication: Acquired Haemophilia

Other drugs received by patient: Prednisolone; Ampicillin and Sulbactam; Metamizole; Sodium Bicarbonate; Ampicillin Sodium; Amiodarone HCL; Pantoprazole Sodium; Magnesium Diasporal; Furosemide; Sodium Chloride 0.9% IN Plastic Container; Codeine Sulfate; Codeine Phosphate; Factor Xiii (Fibrin Stabilising Factor); Morphine; Azuprostat; Atarax; Berotec; Metamizole; Blood Transfusion, Auxiliary Products

Possible Novoseven side effects / adverse reactions in 26 year old female

Reported by a physician from France on 2011-10-26

Patient: 26 year old female

Reactions: Necrosis Ischaemic, Uterine Disorder, Metrorrhagia

Adverse event resulted in: hospitalization

Suspect drug(s):
Cerazette (Desogestrel /00754001/)
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-05-22

Novoseven
    Dosage: 7 mg;qd;iv
    Indication: Haemorrhage
    Start date: 2010-05-20
    End date: 2010-05-20

Nalador (Sulprostone)
    Dosage: iv
    Indication: Haemorrhage
    Start date: 2010-05-19
    End date: 2010-05-19

Clottafact (Factor I (Fibrinogen))
    Dosage: 5 df;iv
    Indication: Haemorrhage
    Start date: 2010-05-19
    End date: 2010-05-19

Restorvol (Elohes /01279201/)
    Dosage: 2 l;qd;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-05-20
    End date: 2010-05-20

Other drugs received by patient: Lovenox; Ferrous Sulfate TAB

Possible Novoseven side effects / adverse reactions in 48 year old female

Reported by a physician from Belgium on 2011-11-22

Patient: 48 year old female weighing 62.0 kg (136.4 pounds)

Reactions: Jugular Vein Thrombosis, Epistaxis

Adverse event resulted in: hospitalization

Suspect drug(s):
Novoseven
    Dosage: 6 mg/2 hours, qd
    Indication: Congenital Thrombocyte Disorder
    Start date: 2010-12-14

Novoseven

Novoseven
    Dosage: 6 mg/3hours, qd
    Start date: 2010-12-14

Novoseven
    Dosage: 6 mg/6 hours, qd
    Start date: 2010-12-21

Novoseven
    Dosage: 6 mg/4 hours,qd
    Start date: 2010-12-20

Novoseven
    Dosage: 6 mg/8hours, qd
    Start date: 2010-12-22

Novoseven
    Dosage: 6 mg/24 hrs, qd
    Start date: 2010-12-23
    End date: 2010-12-23

Other drugs received by patient: Plasma-Lyte 56 and Dextrose 5% IN Plastic Container; Propofol; Sodium Chloride; Remifentanil; Venofer; Omeprazole