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Nplate (Romiplostim Subcutaneous) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (28)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Nplate (Romiplostim Subcutaneous) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Nplate side effects in 70 year old male

Reported by a physician from Hungary on 2012-08-06

Patient: 70 year old male

Reactions: Therapeutic Response Decreased, Gastrointestinal Haemorrhage, Mouth Haemorrhage, Haemorrhage, Platelet Count Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-25

Patient: 74 year old male

Reactions: Ileectomy, Thrombosis Mesenteric Vessel

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Prednisone TAB; Folic Acid



Possible Nplate side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-17

Patient: 34 year old female, weighing 88.0 kg (193.6 pounds)

Reactions: Vomiting, Subarachnoid Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Arcoxia; Dexamethasone; Immunglobulin



Possible Nplate side effects in male

Reported by a physician from Italy on 2012-07-06

Patient: male

Reactions: Ileectomy, Thrombosis Mesenteric Vessel

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Folic Acid



Possible Nplate side effects in 60 year old male

Reported by a physician from United States on 2012-06-26

Patient: 60 year old male

Reactions: Dyspnoea, Myelitis, Acute Myeloid Leukaemia, Myelodysplastic Syndrome, Orthostatic Hypotension, Death, Neurotoxicity, Neoplasm Malignant, Adrenal Insufficiency, Brain Oedema, Carbon Dioxide Decreased, Graft Loss, Jugular Vein Thrombosis

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

Drug(s) suspected as cause:
Neulasta
    Dosage: 6 mg, unk
    Indication: Product Used FOR Unknown Indication

Nplate
    Dosage: unk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2008-09-24
    End date: 2008-12-07

Nplate
    Dosage: unk

Aranesp
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-10-17

Nplate
    Dosage: unk

Nplate
    Dosage: unk

Nplate
    Dosage: unk

Nplate
    Dosage: unk
    Start date: 2008-09-24
    End date: 2008-12-07

Other drugs received by patient: Immunoglobulins; Naproxen; Prochlorperazine Maleate; Daunorubicin HCL; Dexamethasone; Multivitamin / 00097801 /; Fluticasone Propionate; Azithromycin; Alprazolam; Prednisone; Ondansetron (Zofran); Fludarabine Phosphate; Anti-Thymocyte Globulin NOS; Rituximab; Decadron; Tricor; Blood and Related Products; Prograf; Carboplatin; Ifex; Mesna; Methotrexate; Aloxi; Etoposide; Cytarabine; Potassium Chloride; Metformin HCL; Busulfan; Lipitor; Valtrex; Pentamidine Isethionate; Cellcept; Benadryl; Cisplatin; Mucinex; Detrol LA; Triamterene and Hydrochlorothiazid; Iviglob-EX



Possible Nplate side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-12

Patient: 60 year old male

Reactions: Ischaemic Stroke, Platelet Count Increased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Folic Acid; Lenograstim; Omeprazole



Possible Nplate side effects in 31 year old female

Reported by a physician from Portugal on 2012-05-17

Patient: 31 year old female, weighing 67.0 kg (147.4 pounds)

Reactions: Therapeutic Response Decreased, Platelet Aggregation, Productive Cough, Gingival Bleeding, Viral Infection, Lymphadenopathy, Haematuria, Cough

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate
    Dosage: 3 mug/kg, qwk
    Start date: 2011-02-07
    End date: 2011-03-21

Nplate
    Dosage: 7 mug/kg, qwk
    Start date: 2011-07-05
    End date: 2011-07-05

Nplate
    Dosage: 8 mug/kg, qwk
    Start date: 2011-07-11
    End date: 2011-07-11

Nplate
    Dosage: 10 mug/kg, qwk
    Start date: 2011-07-25
    End date: 2011-07-25

Nplate
    Dosage: 9 mug/kg, qwk
    Start date: 2011-07-18
    End date: 2011-07-18

Nplate
    Dosage: 5 mug/kg, qwk
    Start date: 2011-04-04
    End date: 2011-06-20

Nplate
    Dosage: 4 mug/kg, qwk
    Start date: 2011-03-28
    End date: 2011-03-28

Nplate
    Dosage: 6 mug/kg, qwk
    Start date: 2011-06-27
    End date: 2011-06-27

Nplate
    Dosage: 1 mug/kg, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-05-12
    End date: 2011-01-24

Nplate
    Dosage: 2 mug/kg, qwk
    Start date: 2011-01-31

Other drugs received by patient: Vincristine; Prednisolone; Epsicaprom; Iviglob-EX



Possible Nplate side effects in 43 year old female

Reported by a consumer/non-health professional from United States on 2012-04-20

Patient: 43 year old female, weighing 104.3 kg (229.5 pounds)

Reactions: Thrombosis, Migraine, Vein Disorder, Lymphatic Disorder, Drug Hypersensitivity, Compartment Syndrome, Aortic Thrombosis, Lung Disorder, Subarachnoid Haemorrhage, Pulmonary Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 32 month old male

Reported by a physician from Canada on 2012-04-18

Patient: 32 month old male, weighing 12.0 kg (26.4 pounds)

Reactions: Muscular Weakness

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

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Prevacid; Bactrim; Prednisone; Desferal; Tranexamic Acid



Possible Nplate side effects in 60 year old male

Reported by a physician from United States on 2012-02-23

Patient: 60 year old male

Reactions: Myalgia, Fatigue, Multiple Myeloma, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Corticosteroids



Possible Nplate side effects in 60 year old male

Reported by a physician from United States on 2012-02-20

Patient: 60 year old male

Reactions: Myalgia, Fatigue, Multiple Myeloma, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Corticosteroids



Possible Nplate side effects in 67 year old female

Reported by a physician from United States on 2012-01-31

Patient: 67 year old female, weighing 69.1 kg (152.0 pounds)

Reactions: Jaundice, Confusional State, Agitation, Nausea, Conjunctivitis, Toxicity To Various Agents, Pyrexia, Ascites, Diarrhoea, Lung Neoplasm Malignant, Respiratory Arrest, Abdominal Distension, Bone Marrow Failure, Metastases To Central Nervous System, Cardiac Arrest

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

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Paclitaxel



Possible Nplate side effects in 69 year old male

Reported by a pharmacist from United States on 2012-01-26

Patient: 69 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Renal Failure, Obesity, Ventricular Tachycardia, Atrial Fibrillation, Cardiogenic Shock, Respiratory Distress, Cardiac Failure Congestive

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

Drug(s) suspected as cause:
Nplate

Nplate
    Dosage: 550 mug, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-07-14
    End date: 2011-05-13

Other drugs received by patient: Furosemide; Carvedilol; Insulin Aspart; Levothyroxine Sodium; Amiodarone HCL; Corticosteroids



Possible Nplate side effects in 69 year old male

Reported by a pharmacist from United States on 2012-01-24

Patient: 69 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Renal Failure, Obesity, Ventricular Tachycardia, Atrial Fibrillation, Cardiogenic Shock, Respiratory Distress, Cardiac Failure Congestive

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

Drug(s) suspected as cause:
Nplate
    Dosage: 550 mug, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-07-14
    End date: 2011-05-13

Nplate

Other drugs received by patient: Corticosteroids; Carvedilol; Amiodarone HCL; Insulin Aspart; Furosemide; Levothyroxine Sodium



Possible Nplate side effects in 60 year old male

Reported by a physician from United States on 2012-01-20

Patient: 60 year old male

Reactions: Myalgia, Fatigue, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Corticosteroids



Possible Nplate side effects in 67 year old female

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

Patient: 67 year old female, weighing 69.1 kg (152.0 pounds)

Reactions: Jaundice, Confusional State, Agitation, Nausea, Conjunctivitis, Toxicity To Various Agents, Pyrexia, Ascites, Diarrhoea, Lung Neoplasm Malignant, Bone Marrow Failure, Abdominal Distension, Respiratory Arrest, Cardiac Arrest, Metastases To Central Nervous System

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

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Paclitaxel



Possible Nplate side effects in male

Reported by a physician from Belgium on 2012-01-03

Patient: male

Reactions: Suicidal Ideation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 57 year old female

Reported by a physician from United States on 2011-12-20

Patient: 57 year old female, weighing 51.2 kg (112.5 pounds)

Reactions: Bacteraemia, Staphylococcal Infection, Acute Lymphocytic Leukaemia Recurrent, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Alpha Lipoic Acid; Peridex / 00016001 /; Hydrocortisone; Sargramostim; Oxycodone HCL; Lyrica; Interferon Alpha 1-A; Remeron



Possible Nplate side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-14

Patient: 57 year old female, weighing 51.2 kg (112.5 pounds)

Reactions: Bacteraemia, Staphylococcal Infection, Acute Lymphocytic Leukaemia Recurrent, Thrombocytopenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Hydrocortisone; Sargramostim; Oxycodone HCL; Alpha Lipoic Acid; Interferon Alpha 1-A; Remeron; Peridex / 00016001 /; Lyrica



Possible Nplate side effects in 77 year old female

Reported by a physician from United States on 2011-11-29

Patient: 77 year old female

Reactions: Gastrointestinal Haemorrhage, Venous Thrombosis, Septic Shock, Infectious Peritonitis

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

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Corticosteroids



Possible Nplate side effects in male

Reported by a physician from Belgium on 2011-11-23

Patient: male

Reactions: Suicidal Ideation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 68 year old female

Reported by a physician from United States on 2011-11-21

Patient: 68 year old female

Reactions: Gastrointestinal Haemorrhage, Venous Thrombosis, Septic Shock, Infectious Peritonitis

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

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Corticosteroids



Possible Nplate side effects in male

Reported by a physician from Belgium on 2011-11-10

Patient: male

Reactions: Suicidal Ideation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09

Patient: 59 year old male

Reactions: Myelofibrosis, Fall, Urinary Bladder Haemorrhage, Bone Marrow Reticulin Fibrosis, Death, Bacterial Test Positive, Thrombocytopenia, Haematoma, Hepatosplenomegaly, Gingival Bleeding, Mouth Haemorrhage, Haematuria, General Physical Health Deterioration, Therapeutic Response Decreased, Bacterial Disease Carrier, Haematological Malignancy, Inflammation

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

Drug(s) suspected as cause:
Nplate

Nplate
    Dosage: 8 mug/kg, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-01-25
    End date: 2011-06-17

Rituximab

Nplate

Nplate

Nplate

Nplate

Nplate

Other drugs received by patient: Danazol; Danazol



Possible Nplate side effects in 78 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-11-09

Patient: 78 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Haemolytic Anaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate
    Dosage: 10 mug/kg, unk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2010-02-12
    End date: 2010-12-01

Octagam

Other drugs received by patient: Furosemide; Vytorin; Omeprazole; Dilantin; Prednisolone; Aricept



Possible Nplate side effects in 29 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09

Patient: 29 year old female, weighing 69.8 kg (153.7 pounds)

Reactions: Scleroderma, Cerebrovascular Accident, Abortion Spontaneous, Vaginal Haemorrhage, Viith Nerve Paralysis, Therapeutic Response Decreased, Embolism Venous, Platelet Count Decreased, Deep Vein Thrombosis, Infertility Female

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Corticosteroids; Lisinopril; Topamax; Vicodin; Prednisone; Solu-Medrol; Ativan; Iviglob-EX; Rituximab; Ferrous Sulfate TAB; Coumadin; Danazol; Compazine; Procardia XL; Anzemet; Ambien; Zantac / 00550801 /; Prilosec; Zolpidem



Possible Nplate side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-26

Patient: male

Reactions: Haemolytic Anaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate



Possible Nplate side effects in 83 year old male

Reported by a physician from Netherlands on 2011-10-03

Patient: 83 year old male, weighing 84.0 kg (184.8 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Nplate

Other drugs received by patient: Cyklokapron

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