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Naglazyme (Galsulfase) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Naglazyme (Galsulfase) 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 (196)
Death (29)
Disability (3)

Reports by Reaction Type

Pneumonia (29)Spinal Cord Compression (28)Convulsion (17)Death (7)Bronchospasm (7)Hydrocephalus (6)Infusion Related Reaction (6)Cervical Cord Compression (6)Sleep Apnoea Syndrome (6)Product Quality Issue (5)Dyspnoea (5)Asthma (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Naglazyme (Galsulfase). For a complete list or a specific selection of reports, please use the links above.

Possible Naglazyme side effects in 65 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-27

Patient: 65 year old male

Reactions: Cervical Spinal Stenosis, Lumbar Spinal Stenosis

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in 8 year old male

Reported by a individual with unspecified qualification from Colombia on 2012-08-24

Patient: 8 year old male

Reactions: Jaundice, Hepatomegaly

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Brazil on 2012-08-22

Patient: female

Reactions: Bronchospasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: female, weighing 15.0 kg (33.0 pounds)

Reactions: Cervical Spinal Stenosis

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Albuterol; Flovent; Tylenol W / Codeine



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Brazil on 2012-08-17

Patient: female

Reactions: Dyspnoea, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in male

Reported by a individual with unspecified qualification from Brazil on 2012-08-17

Patient: male, weighing 22.0 kg (48.4 pounds)

Reactions: Visual Acuity Reduced, Carpal Tunnel Syndrome, Conductive Deafness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in male

Reported by a individual with unspecified qualification from Brazil on 2012-08-16

Patient: male, weighing 38.0 kg (83.6 pounds)

Reactions: Acute Respiratory Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a consumer/non-health professional from Chile on 2012-08-14

Patient: female

Reactions: Muscular Weakness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in 18 year old female

Reported by a physician from Colombia on 2012-08-13

Patient: 18 year old female

Reactions: Dizziness, Intracranial Pressure Increased, Headache, Encephalocele

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in 10 year old male

Reported by a consumer/non-health professional from Spain on 2012-08-10

Patient: 10 year old male

Reactions: Convulsion

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in 18 year old female

Reported by a individual with unspecified qualification from Colombia on 2012-08-10

Patient: 18 year old female

Reactions: Dizziness, Headache, Intracranial Pressure Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in male

Reported by a physician from Brazil on 2012-08-09

Patient: male

Reactions: Corneal Transplant

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a physician from Mexico on 2012-08-08

Patient: female, weighing 13.4 kg (29.5 pounds)

Reactions: Vith Nerve Paralysis

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Amoxacilin; Sterimar; Fluticasone Furoate



Possible Naglazyme side effects in male

Reported by a individual with unspecified qualification from United States on 2012-08-08

Patient: male

Reactions: Pneumonia, Pyrexia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in male

Reported by a physician from Japan on 2012-08-07

Patient: male

Reactions: Deafness, Influenza

Drug(s) suspected as cause:
Naglazyme
    Start date: 2006-11-07

Naglazyme
    Start date: 2009-10-06

Naglazyme
    Indication: Mucopolysaccharidosis VI
    Start date: 2008-04-01
    End date: 2009-09-29

Other drugs received by patient: Adaptinol



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Brazil on 2012-08-06

Patient: female, weighing 27.0 kg (59.4 pounds)

Reactions: Procedural Complication

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Brazil on 2012-08-03

Patient: female, weighing 27.0 kg (59.4 pounds)

Reactions: Perforated Ulcer, Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-03

Patient: female, weighing 27.0 kg (59.4 pounds)

Reactions: Procedural Complication

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in 18 year old female

Reported by a individual with unspecified qualification from Colombia on 2012-08-01

Patient: 18 year old female

Reactions: Cardio-Respiratory Arrest, Respiratory Tract Oedema, Aeromona Infection, Bronchial Oedema, Bronchitis, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Colombia on 2012-07-31

Patient: female

Reactions: Convulsion

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a physician from United States on 2012-07-31

Patient: female, weighing 15.0 kg (33.0 pounds)

Reactions: Spinal Cord Compression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in 18 year old female

Reported by a individual with unspecified qualification from Colombia on 2012-07-26

Patient: 18 year old female

Reactions: Respiratory Tract Oedema, Cardio-Respiratory Arrest, Bronchial Oedema, Aeromona Infection, Bronchitis, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a physician from Argentina on 2012-07-25

Patient: female

Reactions: Spinal Cord Compression, Urinary Incontinence, Encopresis

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in 18 year old female

Reported by a physician from Colombia on 2012-07-19

Patient: 18 year old female

Reactions: Respiratory Tract Oedema, Respiratory Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-19

Patient: male

Reactions: Death, Choking, Infusion Related Reaction

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Brazil on 2012-07-19

Patient: female, weighing 27.0 kg (59.4 pounds)

Reactions: Spinal Cord Compression

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Warfarin Sodium; EYE Drops; Cardilon; Acetaminophen; Hixizine



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Brazil on 2012-07-19

Patient: female, weighing 27.0 kg (59.4 pounds)

Reactions: Procedural Complication

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Brazil on 2012-07-19

Patient: female, weighing 27.0 kg (59.4 pounds)

Reactions: Ulcer

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-07-13

Patient: male, weighing 13.0 kg (28.6 pounds)

Reactions: Lower Limb Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naglazyme



Possible Naglazyme side effects in male

Reported by a physician from Japan on 2012-07-13

Patient: male

Reactions: Deafness, Influenza

Drug(s) suspected as cause:
Naglazyme
    Indication: Mucopolysaccharidosis VI
    Start date: 2009-10-06

Naglazyme
    Start date: 2006-11-07

Naglazyme
    Start date: 2008-04-01
    End date: 2009-09-29

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