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Zavesca (Miglustat) - Growth Retardation - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Growth Retardation (8)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Zavesca (Miglustat) where reactions include growth retardation. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Zavesca side effects in female

Reported by a physician from France on 2012-07-03

Patient: female, weighing 10.3 kg (22.7 pounds)

Reactions: Pain, Growth Retardation, General Physical Health Deterioration, Tremor, Convulsion, Nephrolithiasis, Neuropathy Peripheral, Diarrhoea, Interstitial Lung Disease, Bronchiolitis, Thrombocytopenia, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca
    Dosage: 50 mg, tid
    Administration route: Oral
    Start date: 2012-03-01

Zavesca
    Dosage: 50 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-03-01

Zavesca
    Dosage: 50 mg, bid
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-03-01

Zavesca
    Dosage: 50 mg, bid
    Administration route: Oral

Other drugs received by patient: Acetaminophen; Vitamin TAB; Morphine; Amitriptyline HCL; Vitamin K1



Possible Zavesca side effects in female

Reported by a physician from France on 2012-05-30

Patient: female

Reactions: Weight Decreased, Diarrhoea, Neurological Decompensation, Urinary Incontinence, Aphasia, Growth Retardation, Gait Disturbance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 mg, bid
    Administration route: Oral
    Start date: 2010-09-21
    End date: 2011-07-01

Zavesca
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-06-08
    End date: 2010-09-20

Zavesca
    Dosage: unk
    Administration route: Oral
    Start date: 2011-10-01

Zavesca
    Dosage: unk
    Administration route: Oral
    Start date: 2011-08-01
    End date: 2011-09-01

Zavesca
    Dosage: 200 mg, bid
    Administration route: Oral



Possible Zavesca side effects in female

Reported by a physician from France on 2012-05-30

Patient: female

Reactions: Weight Decreased, Dysstasia, Growth Retardation, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2011-09-06

Zavesca
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    End date: 2011-09-05

Zavesca
    Dosage: 200 mg, od
    Administration route: Oral
    Start date: 2010-12-10

Other drugs received by patient: Keppra; Clobazam



Possible Zavesca side effects in female

Reported by a physician from France on 2012-01-30

Patient: female

Reactions: Weight Decreased, Diarrhoea, Neurological Decompensation, Aphasia, Urinary Incontinence, Growth Retardation, Gait Disturbance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Zavesca
    Dosage: 300 mg, qd
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-06-08
    End date: 2010-09-20

Zavesca
    Dosage: 200 mg, bid
    Administration route: Oral
    Start date: 2010-09-21



Possible Zavesca side effects in female

Reported by a physician from France on 2012-01-13

Patient: female

Reactions: Weight Decreased, Vomiting, Dysphagia, Diarrhoea, Enteral Nutrition, Nausea, Gastrointestinal Disorder, Growth Retardation, Decreased Appetite

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Zavesca
    Dosage: 50 mg, bid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2009-07-22

Zavesca
    Dosage: 250 mg, qd
    Administration route: Oral
    Start date: 2009-10-15
    End date: 2010-06-11

Zavesca
    Dosage: 100 mg, bid
    Administration route: Oral
    Start date: 2010-06-13



Possible Zavesca side effects in male

Reported by a physician from Spain on 2011-12-27

Patient: male, weighing 11.5 kg (25.3 pounds)

Reactions: Weight Decreased, Fluid Intake Reduced, Growth Retardation, Concomitant Disease Aggravated, Constipation, Transaminases Increased, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zavesca

Other drugs received by patient: Phenobarbital TAB



Possible Zavesca side effects in female

Reported by a physician from Germany on 2011-12-16

Patient: female, weighing 35.0 kg (77.0 pounds)

Reactions: Weight Decreased, Diarrhoea, Growth Retardation

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 mg, bid
    Administration route: Oral

Zavesca
    Dosage: 200 mg, tid
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2008-09-01
    End date: 2010-07-01

Zavesca
    Dosage: 100 mg, tid
    Administration route: Oral
    Start date: 2010-07-01

Zavesca
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Levetiracetam; Clomipramine HCL; Ethosuximide



Possible Zavesca side effects in female

Reported by a physician from France on 2011-10-13

Patient: female

Reactions: Weight Decreased, Growth Retardation, Convulsion

Drug(s) suspected as cause:
Zavesca
    Dosage: 200 mg, unk
    Administration route: Oral

Zavesca
    Dosage: 200 mg, od
    Administration route: Oral
    Indication: Niemann-Pick Disease
    Start date: 2010-12-10

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