November 13, 2009
FDA warns of particulate contamination of Genzyme injectable productsThe FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of certain lots of Cerezyme (imiglucerase), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alpha), Aldurazyme (laronidase), and Thyrogen (thyrotropin alpha). 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. This problem affects all lots of the products listed above that have the prefix “A” (eg, Lot A12345).
Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen are indicated for the treatment of rare, serious, life-threatening diseases. The FDA is continuing to allow these products to be marketed, but is warning healthcare professionals to be alert for the development of adverse events.
Potential adverse events from IM administration of a contaminated product with foreign particles include local pain, swelling and inflammation. Potential adverse reactions from IV administration of a contaminated product include 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.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190480.htm.