Warning Issued for Cerezyme, Fabrayzme, Myozyme, Aldurazyme, Thyrogen

The FDA and Genzyme have notified health care professionals about the potential for foreign particle contamination of several products used to treat rare, serious and life-threatening diseases.
These Genzyme products are affected:

• Cerezyme (imiglucerase) IV infusion for Gaucher disease
• Fabrazyme (agalsidase beta) IV infusion for Fabry disease
• Myozyme (alglucosidase alpha) IV infusion for Pompe disease
• Aldurazyme (laronidase) IV infusion for Mucopolysaccharidosis Type I
• Thyrogen (thyrotropin alpha) intramuscular injection for thyroid cancer

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

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, as well as anaphylactic, allergic and immune-mediated reactions. The foreign particles could possibly affect how well these products work.

The FDA is acutely aware of the critical need for patients to have continued access to these important products. In reaching its decision to allow these products to continue to be marketed, the agency has carefully considered the potential for serious adverse events, the likelihood the recommendations in this notice will significantly reduce the risk of administration of contaminated products and the lack of FDA-approved therapeutic alternatives for these products.

The FDA is actively investigating the nature of the contamination and seeking immediate implementation of corrective actions to mitigate the situation.

Contact:
FDA
800-332-1088