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Fludara (Fludarabine) - Progressive Multifocal Leukoencephalopathy - Suspected Cause - Side Effect Reports

 
 



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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