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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