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Arixtra (Fondaparinux Subcutaneous) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (36)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Arixtra (Fondaparinux Subcutaneous) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 36   Next >>

Possible Arixtra side effects in female

Reported by a physician from France on 2012-06-29

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Off Label Use, Subdural Haematoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Omeprazole; Tercian; Plavix; Anafranil



Possible Arixtra side effects in female

Reported by a lawyer from France on 2012-06-27

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Gastrointestinal Haemorrhage, Disseminated Intravascular Coagulation, Laryngeal Oedema, Lactic Acidosis, Pallor, Haematemesis, Haemodynamic Instability, Off Label Use, Cardio-Respiratory Arrest, Cyanosis, Hepatocellular Injury, Blood Pressure Immeasurable, Mydriasis, General Physical Health Deterioration, Arrhythmia, Pigmentation Disorder, Bradycardia, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Arixtra
    Dosage: 7.5mg per day
    Indication: Atrial Fibrillation
    Start date: 2011-01-17
    End date: 2011-01-27

Prednisolone
    Dosage: 3tab in the morning
    Administration route: Oral
    Indication: Cough
    Start date: 2011-01-18
    End date: 2011-01-22

Other drugs received by patient: Xanax; Acetaminophen; Calcium Carbonate; Boniva; Paroxetine; Acamprosate Calcium; Cefazolin; Dressing; Levothyroxine Sodium; Lasix; Biseptine; Pentoxifylline; Propranolol; Digoxin; Lovenox; Zolpidem; Compresses; Vastarel; Arimidex



Possible Arixtra side effects in female

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

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Mydriasis, Gastrointestinal Haemorrhage, Disseminated Intravascular Coagulation, Lactic Acidosis, Pallor, Haemodynamic Instability, Haematemesis, Off Label Use, Cardio-Respiratory Arrest, Cyanosis, Hepatocellular Injury, Pigmentation Disorder, Bradycardia, Blood Pressure Immeasurable, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Arixtra
    Dosage: 7.5mg per day
    Indication: Atrial Fibrillation
    Start date: 2011-01-17
    End date: 2011-01-27

Prednisolone
    Dosage: 3tab in the morning
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-18

Other drugs received by patient: Calcium Carbonate; Propranolol; Lasix; Boniva; Paroxetine; Dressing; Levothyroxine Sodium; Pentoxifylline; Lovenox; Digoxin; Acetaminophen; Acamprosate Calcium; Zolpidem; Arimidex; Cefazolin; Vastarel; Arimidex; Xanax; Biseptine; Compresses



Possible Arixtra side effects in male

Reported by a consumer/non-health professional from France on 2012-06-08

Patient: male

Reactions: Off Label Use, Mydriasis, Subdural Haematoma, Coma, Hemiparesis, Headache, Cerebral Haemorrhage

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

Drug(s) suspected as cause:
Lovenox
    Dosage: .4ml per day
    Indication: Thrombosis Prophylaxis
    Start date: 2009-07-18
    End date: 2009-07-20

Arixtra
    Dosage: 2.5mg per day
    Indication: Thrombosis Prophylaxis
    Start date: 2009-07-21
    End date: 2009-07-22



Possible Arixtra side effects in 83 year old female

Reported by a physician from France on 2012-06-06

Patient: 83 year old female, weighing 60.0 kg (132.0 pounds)

Reactions: Agitation, Confusional State, Encephalomalacia, Dilatation Ventricular, Disorientation, Somnolence, Convulsion, Off Label Use, Cerebellar Haematoma, Nervous System Disorder, Disturbance in Attention, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra
    Dosage: 7.5mg per day
    Indication: Atrial Fibrillation
    End date: 2012-04-12

Pentoxifylline
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Atrial Fibrillation
    End date: 2012-04-12

Other drugs received by patient: Irbesartan and Hydrochlorothiazide; Bisoprolol Fumarate; Vitamin D; Fenofibrate; Rhinocort; Cordarone; Nexium; Lercanidipine



Possible Arixtra side effects in 83 year old female

Reported by a physician from France on 2012-05-25

Patient: 83 year old female

Reactions: Agitation, Confusional State, Encephalomalacia, Dilatation Ventricular, Disorientation, Somnolence, Convulsion, Off Label Use, Cerebellar Haematoma, Nervous System Disorder, Disturbance in Attention, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra
    Dosage: 7.5mg per day
    Indication: Atrial Fibrillation
    End date: 2012-04-12

Pentoxifylline
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Atrial Fibrillation
    End date: 2012-04-12

Other drugs received by patient: Rhinocort; Cordarone; Lercanidipine; Nexium; Irbesartan; Bisoprolol Fumarate; Vitamin D; Fenofibrate



Possible Arixtra side effects in 76 year old male

Reported by a physician from France on 2012-05-16

Patient: 76 year old male

Reactions: Off Label Use, Coma, Cerebral Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Novolog; Baclofen; Amaryl; Acetaminophen; Folic Acid; Toco 500



Possible Arixtra side effects in female

Reported by a physician from France on 2012-05-11

Patient: female, weighing 115.0 kg (253.0 pounds)

Reactions: Off Label Use, Injection Site Haematoma, Oedema Peripheral, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-05

Arixtra
    Dosage: 7.5mg per day
    Indication: Deep Vein Thrombosis
    Start date: 2012-02-01
    End date: 2012-02-05

Other drugs received by patient: Paroxetine; Atarax; Diamicron; Acetaminophen; Piascledine; Acetaminophen; Beclomethasone Dipropionate + Formoterol; Fenofibrate; Metformin HCL; Bromazepam; Moviprep; Zopiclone; Nexium; Levemir; Indapamide; Oxygen Therapy



Possible Arixtra side effects in 69 year old female

Reported by a physician from France on 2012-05-07

Patient: 69 year old female

Reactions: Off Label Use, Hyperthermia, Purpura, Toxic Skin Eruption, Eosinophilia, Prurigo

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-09

Pyostacine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-07
    End date: 2010-08-09

Arixtra
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-08-07
    End date: 2010-08-09



Possible Arixtra side effects in female

Reported by a physician from France on 2012-04-23

Patient: female

Reactions: Off Label Use, Injection Site Haematoma, Oedema Peripheral, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-04

Arixtra
    Dosage: 7.5mg per day
    Indication: Deep Vein Thrombosis
    Start date: 2012-02-01
    End date: 2012-02-05

Other drugs received by patient: Bromazepam; Beclomethasone Dipropionate + Formoterol; Levemir; Metformin HCL; Acetaminophen; Paroxetine; Atarax; Indapamide; Piascledine; Nexium; Fenofibrate; Zopiclone; Oxygen Therapy; Diamicron; Moviprep; Acetaminophen



Possible Arixtra side effects in female

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

Patient: female

Reactions: Muscle Haemorrhage, Off Label Use, Skin Lesion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Depakote; Oxazepam; Zolpidem Tartrate; Sulfarlem; Paroxetine Hydrochloride; Zoloft; Aspirin; Risperdal; Polyethylene Glycol



Possible Arixtra side effects in male

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

Patient: male

Reactions: Pain in Extremity, Anaemia, Groin Pain, Muscle Haemorrhage, Off Label Use, Arthropathy, Overdose, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Kerlone; Olmesartan Medoxomil; Mediatensyl; Aspirin; Esidrix; Zolpidem Tartrate; Lercanidipine



Possible Arixtra side effects in female

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

Patient: female

Reactions: Off Label Use, Heparin-Induced Thrombocytopenia, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra



Possible Arixtra side effects in male

Reported by a physician from France on 2012-04-12

Patient: male

Reactions: Off Label Use, Dermatitis Allergic, Pruritus Generalised, Rash Erythematous

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Cordarone



Possible Arixtra side effects in 75 year old female

Reported by a physician from France on 2012-04-12

Patient: 75 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Off Label Use, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Lercanidipine; Atenolol



Possible Arixtra side effects in 74 year old male

Reported by a physician from France on 2012-04-09

Patient: 74 year old male, weighing 79.0 kg (173.8 pounds)

Reactions: Off Label Use, Incorrect Drug Administration Duration, Haematoma

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Atorvastatin; Furosemide; Acetaminophen and Tramadol HCL; Omeprazole; Bisoprolol Fumarate; Acetaminophen and Codeine Phosphate



Possible Arixtra side effects in 51 year old female

Reported by a physician from France on 2012-04-05

Patient: 51 year old female

Reactions: Muscle Haemorrhage, Off Label Use

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra
    Dosage: 7.5mg per day
    Indication: Deep Vein Thrombosis
    Start date: 2012-03-04
    End date: 2012-03-10

Aspirin
    Dosage: 75mg per day
    Administration route: Oral
    Indication: Prophylaxis

Other drugs received by patient: Paroxetine Hydrochloride; Zoloft; Depakote; Risperdal; Oxazepam; Sulfarlem; Zolpidem Tartrate



Possible Arixtra side effects in female

Reported by a consumer/non-health professional from France on 2012-04-02

Patient: female

Reactions: Off Label Use, Heparin-Induced Thrombocytopenia, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra



Possible Arixtra side effects in female

Reported by a physician from France on 2012-03-30

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Off Label Use, Subdural Haematoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Anafranil; Tercian; Plavix; Omeprazole



Possible Arixtra side effects in female

Reported by a physician from France on 2012-03-29

Patient: female

Reactions: Agitation, Gastrointestinal Haemorrhage, Vomiting, Hypotension, Anaemia, Muscular Weakness, Fall, Haematemesis, Off Label Use, Blood Creatinine, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Previscan
    Dosage: 10mg per day
    Administration route: Oral
    Indication: Atrial Flutter
    Start date: 2011-02-21

Arixtra
    Dosage: 7.5mg per day
    Indication: Atrial Flutter
    Start date: 2011-02-21
    End date: 2011-02-24

Other drugs received by patient: Citalopram Hydrobromide; Levothyroxine Sodium; Flecainide Acetate; Pravastatin; Bisoprolol Fumarate; Lorazepam; Digoxin; Cordarone; Omeprazole



Possible Arixtra side effects in 75 year old female

Reported by a physician from France on 2012-03-26

Patient: 75 year old female

Reactions: Off Label Use, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Atenolol; Lercanidipine



Possible Arixtra side effects in female

Reported by a physician from France on 2012-03-09

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Off Label Use, Subdural Haematoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Plavix; Omeprazole; Anafranil; Tercian



Possible Arixtra side effects in female

Reported by a physician from France on 2012-03-09

Patient: female

Reactions: Muscle Haemorrhage, Off Label Use, Incorrect Drug Administration Duration, Anaemia, Walking Disability

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Bisoprolol Fumarate; Pantoprazole; Furosemide; Zolpidem



Possible Arixtra side effects in male

Reported by a physician from Germany on 2012-03-08

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Off Label Use, Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Metoprolol Tartrate; Clopidogrel



Possible Arixtra side effects in male

Reported by a physician from Germany on 2012-03-05

Patient: male

Reactions: Off Label Use, Haemorrhage

Drug(s) suspected as cause:
Arixtra



Possible Arixtra side effects in male

Reported by a physician from France on 2012-03-02

Patient: male

Reactions: Off Label Use, Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Previscan
    Dosage: 20mg see dosage text
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-01

Arixtra
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2011-09-06

Other drugs received by patient: Corvasal; Atenolol; Omeprazole; Nitroderm; Aldactone; Depakene; Amlodipine Besylate; Prozac; Enalapril Maleate and Hydrochlorothiazide



Possible Arixtra side effects in female

Reported by a physician from France on 2012-02-27

Patient: female

Reactions: Off Label Use, Subdural Haematoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Omeprazole; Plavix; Anafranil; Tercian



Possible Arixtra side effects in 48 year old male

Reported by a physician from France on 2012-02-24

Patient: 48 year old male

Reactions: Off Label Use, Anaemia, Asthenia, Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra

Other drugs received by patient: Daflon; UN-Alpha; Potassium Chloride; Polyethylene Glycol; Lasix; Omeprazole; Loxen; Atorvastatin



Possible Arixtra side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-16

Patient: 57 year old male, weighing 187.0 kg (411.4 pounds)

Reactions: Off Label Use, Haemorrhage, Superinfection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Arixtra



Possible Arixtra side effects in 84 year old female

Reported by a pharmacist from France on 2012-01-20

Patient: 84 year old female, weighing 67.0 kg (147.4 pounds)

Reactions: Off Label Use, Injection Site Haematoma, Anaemia, Haematoma

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Indication: Venous Stent Insertion
    Start date: 2011-01-01

Arixtra
    Dosage: 7.5mg per day
    Indication: Arrhythmia
    Start date: 2011-12-19

Plavix
    Administration route: Oral
    Indication: Venous Stent Insertion
    Start date: 2011-01-01



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