FDA, Genzyme Issue Safety Alert for Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen

The Food and Drug Administration and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several products that are used to treat rare, serious, and life-threatening diseases.

The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients.

The affected products include:

Cerezyme (imiglucerase) for Gaucher disease – intravenous (IV) infusion
Fabrazyme (agalsidase beta) for Fabry disease – IV infusion
Myozyme (alglucosidase alpha) for Pompe disease – IV infusion
Aldurazyme (laronidase) for Mucoploysaccharidosis Type I – IV infusion
Thyrogen (thyrotropin alpha) used as an adjunctive diagnostic tool and treatment for thyroid cancer – Intramuscular (IM) injection

Potential adverse events from intramuscular administration of a contaminated product could include local pain, swelling and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. It is also possible that the foreign particles could affect how well these products work.

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Published on Nov-13-09