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Naglazyme (Galsulfase) - Product Quality Issue - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Product Quality Issue (5)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Naglazyme (Galsulfase) where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Sweden on 2012-04-23

Patient: female, weighing 14.5 kg (31.9 pounds)

Reactions: Product Quality Issue, Anaphylactic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Atropine; Oxygen; Epinephrine; Morphine; Loratadine; Solu-Cortef; Tribonat; Hydrocortisone; Acetaminophen



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Sweden on 2012-04-02

Patient: female, weighing 14.5 kg (31.9 pounds)

Reactions: Product Quality Issue, Anaphylactic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Acetaminophen; Hydrocortisone; Atropine; Morphine; Epinephrine; Solu-Cortef; Tribonat; Oxygen



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Sweden on 2012-01-09

Patient: female, weighing 14.5 kg (31.9 pounds)

Reactions: Product Quality Issue, Anaphylactic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Atropine; Morphine; Tribonat; Solu-Cortef; Oxygen; Epinephrine; Acetaminophen



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Sweden on 2011-12-16

Patient: female, weighing 14.5 kg (31.9 pounds)

Reactions: Product Quality Issue, Anaphylactic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Solu-Cortef; Atropine; Acetaminophen; Oxygen; Epinephrine; Morphine; Tribonat



Possible Naglazyme side effects in female

Reported by a individual with unspecified qualification from Sweden on 2011-11-15

Patient: female, weighing 14.5 kg (31.9 pounds)

Reactions: Product Quality Issue, Hypersensitivity

Adverse event resulted in: death

Drug(s) suspected as cause:
Naglazyme

Other drugs received by patient: Acetaminophen; Atropine; Oxygen; Solu-Cortef

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