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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