Index of reports
> Cases with Progressive Multifocal Leukoencephalopathy (13)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fludara (Fludarabine) where reactions include progressive multifocal leukoencephalopathy. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Fludara side effects in male
Reported by a consumer/non-health professional from Denmark on 2012-07-19
Patient: male
Reactions: Muscular Weakness, Coordination Abnormal, Progressive Multifocal Leukoencephalopathy, Tremor, Paraesthesia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mabthera
Dosage: every 2 weeks, maintainance every 2 months
Start date: 2010-07-14
End date: 2011-07-19
Mabthera
Dosage: 230 df, q2w
Indication: Chronic Lymphocytic Leukaemia Refractory
Start date: 2007-02-20
End date: 2007-03-14
Cyclophosphamide
Dosage: unk
Indication: Haemolysis
Mabthera
Dosage: q4w
Indication: Haemolysis
Start date: 2009-06-28
End date: 2009-11-17
Fludara
Dosage: unk
Indication: Chronic Lymphocytic Leukaemia
Cyclophosphamide
Dosage: 100 mg, unk
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2007-02-20
End date: 2007-05-29
Other drugs received by patient: Chlorambucil; Chlorambucil; Prednisolone
Possible Fludara side effects in
Reported by a consumer/non-health professional from Germany on 2012-06-21
Patient:
Reactions: Sepsis, Progressive Multifocal Leukoencephalopathy, Meningitis Tuberculous
Adverse event resulted in: death
Drug(s) suspected as cause:
Cisplatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Neupogen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Rituxan
Dosage: unk
Indication: Product Used FOR Unknown Indication
Cyclophosphamide
Dosage: 2000 mg/m2, unk
Indication: Product Used FOR Unknown Indication
Carboplatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Etoposide
Dosage: unk
Indication: Product Used FOR Unknown Indication
Zevalin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Prednisone TAB
Dosage: unk
Indication: Product Used FOR Unknown Indication
Busulfan
Dosage: 12 mg/kg, unk
Indication: Product Used FOR Unknown Indication
Fludara
Dosage: 250 mg/m2, unk
Indication: Product Used FOR Unknown Indication
Doxorubicin Hydrochloride
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ifosfamide
Dosage: unk
Indication: Product Used FOR Unknown Indication
Vincristine Sulfate
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Fludara side effects in
Reported by a consumer/non-health professional from Canada on 2012-06-13
Patient:
Reactions: Sepsis, Progressive Multifocal Leukoencephalopathy, Meningitis Tuberculous
Adverse event resulted in: death
Drug(s) suspected as cause:
Neupogen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Rituxan
Dosage: unk
Indication: Product Used FOR Unknown Indication
Busulfan
Dosage: 12 mg/kg, qd
Indication: Product Used FOR Unknown Indication
Cisplatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Cyclophosphamide
Dosage: 2000 mg/m2, qd
Indication: Product Used FOR Unknown Indication
Etoposide
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ifosfamide
Dosage: unk
Indication: Product Used FOR Unknown Indication
Zevalin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Prednisone TAB
Dosage: unk
Indication: Product Used FOR Unknown Indication
Vincristine Sulfate
Dosage: unk
Indication: Product Used FOR Unknown Indication
Fludara
Dosage: 250 mg/m2, qd
Indication: Product Used FOR Unknown Indication
Doxorubicin Hydrochloride
Dosage: unk
Indication: Product Used FOR Unknown Indication
Carboplatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Fludara side effects in male
Reported by a consumer/non-health professional from Denmark on 2012-06-07
Patient: male
Reactions: Muscular Weakness, Coordination Abnormal, Progressive Multifocal Leukoencephalopathy, Tremor, Paraesthesia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mabthera
Dosage: q4w
Start date: 2009-06-28
End date: 2009-11-17
Mabthera
Dosage: 230 df, q2w
Indication: Chronic Lymphocytic Leukaemia Refractory
Start date: 2007-02-20
End date: 2007-03-14
Mabthera
Dosage: every 2 weeks, maintainance every 2 months
Indication: Haemolysis
Cyclophosphamide
Dosage: 100 mg, unk
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2007-02-20
End date: 2007-05-29
Cyclophosphamide
Dosage: unk
Indication: Haemolysis
Fludara
Dosage: unk
Indication: Chronic Lymphocytic Leukaemia
Other drugs received by patient: Chlorambucil; Chlorambucil; Prednisolone
Possible Fludara side effects in
Reported by a health professional (non-physician/pharmacist) from Latvia on 2012-04-30
Patient:
Reactions: Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fludara
Other drugs received by patient: Mitoxantrone; Dexamethasone
Possible Fludara side effects in male
Reported by a physician from Finland on 2012-03-21
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fludara
Dosage: 30 mg, qdx3
Administration route: Oral
Start date: 2009-10-06
Cyclophosphamide
Dosage: 450 mg, qdx3
Administration route: Oral
Start date: 2009-07-16
Campath
Dosage: 30 mg, once
Start date: 2009-09-10
End date: 2009-09-10
Cyclophosphamide
Dosage: 350 mg, qdx3
Administration route: Oral
Start date: 2009-08-12
Campath
Dosage: 30 mg, once
Start date: 2009-08-12
End date: 2009-08-12
Cyclophosphamide
Dosage: 450 mg, qdx3
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2009-06-19
Cyclophosphamide
Dosage: 350 mg, qdx3
Administration route: Oral
Start date: 2009-10-06
Cyclophosphamide
Dosage: 350 mg, qdx3
Administration route: Oral
Start date: 2009-09-10
Campath
Dosage: 30 mg, once
Start date: 2009-07-16
End date: 2009-07-16
Fludara
Dosage: 40 mg, qdx3
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2009-06-19
Fludara
Dosage: 40 mg, qdx3
Administration route: Oral
Start date: 2009-07-16
Fludara
Dosage: 30 mg, qdx3
Administration route: Oral
Start date: 2009-09-10
Campath
Dosage: 30 mg, once
Indication: Chronic Lymphocytic Leukaemia
Start date: 2009-06-17
End date: 2009-06-17
Fludara
Dosage: 30 mg, qdx3
Administration route: Oral
Start date: 2009-08-12
Possible Fludara side effects in male
Reported by a physician from Finland on 2012-02-28
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 450 mg, qdx3
Start date: 2009-07-16
Campath
Dosage: 30 mg, once
Start date: 2009-09-10
End date: 2009-09-10
Fludara
Dosage: 30 mg, qdx3
Start date: 2009-10-06
Campath
Dosage: 30 mg, once
Start date: 2009-08-12
End date: 2009-08-12
Fludara
Dosage: 30 mg, qdx3
Start date: 2009-08-12
Cyclophosphamide
Dosage: 350 mg, qdx3
Start date: 2009-10-06
Campath
Dosage: 30 mg, once
Start date: 2009-07-16
End date: 2009-07-16
Cyclophosphamide
Dosage: 450 mg, qdx3
Indication: Chronic Lymphocytic Leukaemia
Start date: 2009-06-19
Cyclophosphamide
Dosage: 350 mg, qdx3
Start date: 2009-08-12
Campath
Dosage: 30 mg, once
Indication: Chronic Lymphocytic Leukaemia
Start date: 2009-06-17
End date: 2009-06-17
Fludara
Dosage: 40 mg, qdx3
Start date: 2009-07-16
Fludara
Dosage: 40 mg, qdx3
Indication: Chronic Lymphocytic Leukaemia
Start date: 2009-06-19
Fludara
Dosage: 30 mg, qdx3
Start date: 2009-09-10
Cyclophosphamide
Dosage: 350 mg, qdx3
Start date: 2009-09-10
Possible Fludara side effects in female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-02-03
Patient: female
Reactions: JC Virus Test Positive, Dysarthria, Adverse Drug Reaction, Hearing Impaired, Cognitive Disorder, Hemiplegia, Pyrexia, Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
End date: 2011-03-01
Mabthera
Dosage: 800 mg, 4 times
Mabthera
Dosage: 800 mg, 4 times
End date: 2011-04-15
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Fludara
Dosage: unk; 5 cures
Administration route: Oral
Fludara
Dosage: unk; 5 cures
Administration route: Oral
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
Mabthera
Dosage: 800 mg, 4 times
Fludara
Dosage: unk; 5 cures
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Mabthera
Dosage: 800 mg, 4 times
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-01-13
Fludara
Dosage: unk; 5 cures
Administration route: Oral
Fludara
Dosage: unk; 5 cures
Administration route: Oral
End date: 2011-03-01
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Other drugs received by patient: Eprex; Spiriva; Oxis Turbuhaler; Acyclovir; Bactrim
Possible Fludara side effects in female
Reported by a physician from Germany on 2012-01-18
Patient: female
Reactions: JC Virus Test Positive, Dysarthria, Adverse Drug Reaction, Hearing Impaired, Hemiplegia, Cognitive Disorder, Pyrexia, Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
Mabthera
Dosage: 800 mg, 4 times
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-01-13
Fludara
Dosage: unk; 5 cures
End date: 2011-03-01
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Fludara
Dosage: unk; 5 cures
Mabthera
Dosage: 800 mg, 4 times
Mabthera
Dosage: 800 mg, 4 times
End date: 2011-04-15
Fludara
Dosage: unk; 5 cures
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
End date: 2011-03-01
Fludara
Dosage: unk; 5 cures
Cyclophosphamide
Dosage: unk; 5 cures
Administration route: Oral
Fludara
Dosage: unk; 5 cures
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
Mabthera
Dosage: 800 mg, 4 times
Other drugs received by patient: Spiriva; Bactrim; Oxis Turbuhaler; Eprex; Acyclovir
Possible Fludara side effects in
Reported by a health professional (non-physician/pharmacist) from Latvia on 2012-01-16
Patient:
Reactions: Death, Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Fludara
Other drugs received by patient: Mitoxantrone; Dexamethasone
Possible Fludara side effects in 65 year old male
Reported by a physician from Germany on 2011-10-24
Patient: 65 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: 150 mg/m2, days 1-3
Indication: Chronic Lymphocytic Leukaemia
Rituximab
Dosage: 500 mg/m2, days 1,14
Indication: Chronic Lymphocytic Leukaemia
Fludara
Dosage: 20 mg/m2, days 1-3
Indication: Chronic Lymphocytic Leukaemia
Other drugs received by patient: Flecainide Acetate
Possible Fludara side effects in female
Reported by a physician from Sweden on 2011-10-13
Patient: female
Reactions: Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death
Drug(s) suspected as cause:
Mabthera
Dosage: mabthera conc for solution for infusion, dose 800 mg4
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-01-13
End date: 2011-04-15
Fludara
Dosage: dose cc, fludara fc tacl
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
End date: 2011-03-01
Cyclophosphamide
Dosage: sendoxn, dose cc.
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
End date: 2011-03-01
Other drugs received by patient: Oxis Turbohaler; Bactrim DS; Acyclovir; Eprex; Spiriva
Possible Fludara side effects in 51 year old female
Reported by a health professional (non-physician/pharmacist) from Sweden on 2011-10-06
Patient: 51 year old female
Reactions: Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Cyclophosphamide
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
End date: 2011-03-01
Mabthera
Indication: Chronic Lymphocytic Leukaemia
Start date: 2011-01-13
End date: 2011-04-15
Fludara
Administration route: Oral
Indication: Chronic Lymphocytic Leukaemia
Start date: 2010-11-01
End date: 2011-03-01
Other drugs received by patient: Acyclovir; Eprex / UNK /; Formoterol Fumarate; Tiopronin; Bactrim DS
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