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Winrho SDF (RHO D Immune Globulin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Winrho SDF (RHO D Immune Globulin) 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 (21)
Death (3)
Life Threatening Events (3)
Disability (1)

Reports by Reaction Type

Chills (8)Headache (6)Nausea (6)Haemolysis (6)Haemoglobin Decreased (6)Pyrexia (4)Overdose (4)Chest Pain (4)Blood Lactate Dehydrogenase Increased (4)Abdominal Pain (3)Drug Ineffective (3)Dyspnoea (3)

Possible Winrho SDF side effects in female

Reported by a physician from United States on 2012-08-05

Patient: female, weighing 110.0 kg (242.0 pounds)

Reactions: Confusional State, Electrocardiogram ST-T Change, Respiratory Disorder, Chills, Mental Status Changes, Pyrexia, Haemodynamic Instability, Activated Partial Thromboplastin Time Prolonged, Meningitis, Acute Respiratory Failure, Blood Glucose Increased, Lethargy, Blood Alkaline Phosphatase Increased, Pneumonia, Restlessness, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Hypotension, Encephalopathy, Status Epilepticus, Blood Bicarbonate Decreased, Concomitant Disease Progression, Blood Lactic Acid Increased, Convulsion, Aggression, Renal Failure, Aspartate Aminotransferase Increased, Depressed Level of Consciousness, Blood Pressure Decreased, Asthenia, Sinus Tachycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Winrho SDF
    Dosage: (45.45 ug/kg total intravenous (not otherwise specified), (intravenous (not otherwise specified)
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-06-28
    End date: 2011-06-28

Winrho SDF
    Dosage: (45.45 ug/kg total intravenous (not otherwise specified), (intravenous (not otherwise specified)
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-06-28
    End date: 2011-06-28

Winrho SDF

Other drugs received by patient: Wellbutrin; Celexa; Zithromax; Theraflu; Celebrex; Nuvaring



Possible Winrho SDF side effects in female

Reported by a pharmacist from United States on 2012-07-23

Patient: female, weighing 139.6 kg (307.1 pounds)

Reactions: Nausea, Chills, Blood Lactate Dehydrogenase Increased, Pyrexia, Headache, Haemolysis, Haemoglobin Decreased, Platelet Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Hydrocortisone; Tylenol; Benadryl



Possible Winrho SDF side effects in male

Reported by a physician from United States on 2012-06-22

Patient: male, weighing 100.2 kg (220.5 pounds)

Reactions: Abdominal Pain, Disseminated Intravascular Coagulation, Somnolence, Cardiomegaly, Activated Partial Thromboplastin Time Prolonged, Overdose, Fatigue, Ventricular Hypertrophy, Hepatomegaly, Chest Pain, Poor Peripheral Circulation, Thyroiditis Chronic, Myocardial Infarction, Hepatosplenomegaly, Back Pain, Dyspnoea, Vomiting, Nausea, Benign Prostatic Hyperplasia, Myopathy, Arrhythmia, Haemolysis, Convulsion, Arteriosclerosis Coronary Artery

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

Drug(s) suspected as cause:
Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2006-09-22
    End date: 2006-09-22

Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2006-09-22
    End date: 2006-09-22

Winrho SDF

Other drugs received by patient: Flomax; Antihypertensives; Glucophage



Possible Winrho SDF side effects in 65 year old male

Reported by a pharmacist from United States on 2012-06-07

Patient: 65 year old male, weighing 101.6 kg (223.5 pounds)

Reactions: Overdose, Haemolytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Antineoplastic Agents



Possible Winrho SDF side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04

Patient: female

Reactions: Blood Urine Present, Chromaturia, Condition Aggravated

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Alinia



Possible Winrho SDF side effects in male

Reported by a physician from Canada on 2012-05-18

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Overdose, Chills, Haemolytic Transfusion Reaction

Drug(s) suspected as cause:
Winrho SDF
    Dosage: (73 ug/kg total)
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-12-15
    End date: 2011-12-15

Winrho SDF
    Dosage: (73 ug/kg total)
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-12-15
    End date: 2011-12-15

Winrho SDF

Other drugs received by patient: Ribavirin; Peginterferon Alfa-2A; Prednisone; Epogen; APO-Cyclosporine



Possible Winrho SDF side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-27

Patient: female

Reactions: Anxiety, Flushing, Hypersensitivity, Nausea, Chills, Tachycardia, Pain, Headache

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Solucortef; Benadryl



Possible Winrho SDF side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-12

Patient: female

Reactions: Anxiety, Dyspnoea, Chest Pain, Maternal Exposure During Pregnancy, Anaphylactic Reaction, Cardiomegaly

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Winrho SDF



Possible Winrho SDF side effects in 81 year old female

Reported by a physician from United States on 2012-04-12

Patient: 81 year old female

Reactions: Thrombosis, Abdominal Pain, Pneumonia Aspiration, Drug Ineffective, Mental Status Changes, Prothrombin Time Prolonged, Cerebral Haemorrhage, Cardio-Respiratory Arrest, Platelet Morphology Abnormal, Fibrin D Dimer Increased, Chest Pain, Embolic Stroke, International Normalised Ratio Increased, Cerebral Atrophy, Encephalopathy, Status Epilepticus, Cerebellar Haemorrhage, Blood Fibrinogen Increased, Brain Stem Syndrome, Intravascular Haemolysis, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Iron; Methylprednisolone



Possible Winrho SDF side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-12

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Abdominal Pain, Pneumonia Aspiration, Unresponsive To Stimuli, Cerebrovascular Disorder, Prothrombin Time Prolonged, Cerebral Haemorrhage, Fibrin D Dimer Increased, Meningitis, Gallbladder Disorder, Pain in Extremity, Troponin Increased, Cerebellar Haemorrhage, Blood Fibrinogen Increased, Brain Stem Syndrome, Depressed Level of Consciousness, Haemolytic Anaemia, Metabolic Encephalopathy, Confusional State, Drug Ineffective, Chills, Transfusion Reaction, Somnolence, Platelet Morphology Abnormal, Overdose, Marrow Hyperplasia, Cardio-Respiratory Arrest, Chest Pain, Embolic Stroke, Autoimmune Thrombocytopenia, Lethargy, Nausea, Urinary Tract Infection, Cerebral Atrophy, Status Epilepticus, Mental Impairment, Epigastric Discomfort, Leukocytosis, Sinus Tachycardia, Lung Infiltration, Infection

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

Drug(s) suspected as cause:
Winrho SDF



Possible Winrho SDF side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-27

Patient: male, weighing 68.2 kg (150.0 pounds)

Reactions: Haemoglobin Decreased, Drug Dispensing Error, Haemolysis

Drug(s) suspected as cause:
Winrho SDF
    Dosage: 51.17 ?g/kg total intravenous (not otherwise specified), (intravenous (not otherwise specified))
    Indication: Autoimmune Thrombocytopenia
    Start date: 2012-03-07
    End date: 2012-03-07

Winrho SDF
    Dosage: 51.17 ?g/kg total intravenous (not otherwise specified), (intravenous (not otherwise specified))
    Indication: Autoimmune Thrombocytopenia
    Start date: 2012-03-07
    End date: 2012-03-07

Winrho SDF



Possible Winrho SDF side effects in

Reported by a physician from United States on 2012-03-21

Patient:

Reactions: Urine Colour Abnormal, Headache

Drug(s) suspected as cause:
Winrho SDF



Possible Winrho SDF side effects in

Reported by a physician from United States on 2012-03-21

Patient:

Reactions: Urine Colour Abnormal, Headache

Drug(s) suspected as cause:
Winrho SDF



Possible Winrho SDF side effects in female

Reported by a physician from United States on 2012-03-05

Patient: female, weighing 17.4 kg (38.3 pounds)

Reactions: Haemoglobin Decreased, Coombs Test Positive, Haemolysis

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Immune Globulin NOS



Possible Winrho SDF side effects in 4 year old female

Reported by a physician from United States on 2012-02-22

Patient: 4 year old female

Reactions: Haemoglobin Decreased, Anaemia

Drug(s) suspected as cause:
Winrho SDF



Possible Winrho SDF side effects in

Reported by a physician from United States on 2012-02-22

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Winrho SDF



Possible Winrho SDF side effects in female

Reported by a physician from United States on 2012-02-10

Patient: female, weighing 139.6 kg (307.1 pounds)

Reactions: Haemoglobin Decreased, Nausea, Blood Lactate Dehydrogenase Increased, Chills, Laboratory Test Interference, Pyrexia, Headache, Haemolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Benadryl ( TO NOT Continuing); Tylenol ( TO NOT Continuing); Hydrocortisone ( TO NOT Continuing)



Possible Winrho SDF side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-02-06

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Blood Pressure Increased, Blood Urine Present, Dyspnoea, Drug Intolerance, Transfusion Reaction, Drug Prescribing Error, Abdominal Pain Upper, Feeling Hot, Platelet Count Decreased, Infusion Related Reaction

Drug(s) suspected as cause:
Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-08-31
    End date: 2011-08-31

Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-10-12
    End date: 2011-11-16

Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-11-30

Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-08-08
    End date: 2011-08-08

Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-09-07
    End date: 2011-09-21

Winrho SDF
    Dosage: see image
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-09-06
    End date: 2011-09-06

Other drugs received by patient: Nitrolingual; Crestor; Ramipril; Domperidone; Pantoprazole; Diazepam; Voltaren



Possible Winrho SDF side effects in female

Reported by a pharmacist from United States on 2012-01-30

Patient: female

Reactions: Nausea, Chills, Headache, Pyrexia, Haemolysis

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Benadryl; Acetaminophen; Hydrocortisone



Possible Winrho SDF side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-01-11

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Blood Bilirubin Increased, Haptoglobin Decreased, Blood Urine Present, Blood Lactate Dehydrogenase Increased, Chills, Anaemia, Haemolytic Transfusion Reaction, Haemoglobin Decreased

Drug(s) suspected as cause:
Winrho SDF
    Dosage: (73 ug/kg total)
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-12-15
    End date: 2011-12-15

Winrho SDF
    Dosage: (73 ug/kg total)
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-12-15
    End date: 2011-12-15

Winrho SDF

Other drugs received by patient: Peginterferon Alfa-2A; APO-Cyclosporine; Erythrompoietin; Ribavirin; Prednisone



Possible Winrho SDF side effects in 38 year old male

Reported by a individual with unspecified qualification from Canada on 2011-12-19

Patient: 38 year old male, weighing 86.0 kg (189.2 pounds)

Reactions: Anti-Erythrocyte Antibody Positive, Haemolytic Anaemia

Drug(s) suspected as cause:
Winrho SDF

Other drugs received by patient: Piperacillin and Tazobactam; Cyclomen; Acetaminophen; Tranexamic Acid; Furosemide; Nadolol

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