Safety Alerts & Recalls
What does this mean?
At this time, there have been no adverse event reports linked to particle contamination from Fabrazyme. However, you should be aware that infusing solutions with particle contamination can cause adverse effects including pain, swelling, and inflammation at the injection site. More serious adverse effects from infusing contaminated solutions include damage to blood vessels or clotting events, and anaphylactic or allergic reactions. It is also possible that the foreign particles could affect how well this products work.
If you are receiving Fabrazyme infusions, you may want to discuss these new risks with your health care provider - for most patients the benefits of the infusion will continue to outweigh the small risk of particle contamination. Your health care provider can further reduce the risk of infusing a contaminated product by inspecting the solution for particles during preparation and by filtering the solution during administration.
After you receive an infusion of Fabrazyme, watch for redness, pain, discoloration, or hardness at the injection site and contact your doctor or other health care provider if these symptoms occur. If you experience difficulty breathing, rash, chest tightness, or unusual symptoms during and after the infusion, notify your doctor or other health care provider immediately.
Possible Contamination of Fabrazyme
The FDA has issued a warning about the potential for foreign particle contamination of several products made by Genzyme Corporation that are used to treat rare, serious, and life-threatening diseases. The contaminating particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process. It is estimated that foreign particles have occurred in less than 1% of Genzyme's products. This problem affects all lots of Fabrazyme (agalsidase beta) which have the prefix " A" (e.g. Lot A12345).
Fabrazyme (agalsidase beta) is an intravenous (IV) infusion used to treat Fabry disease. Because there is a lack of other FDA-approved treatments for Fabry disease and there is a critical need for a continued access to Fabrazyme, the FDA has decided to allow Fabrazyme to continued to be marketed. However, the FDA has provided recommendations to health care providers for added steps to the preparation and administration of Fabrazyme to reduce the risk of administration of a contaminated product.
The FDA is actively investigating the nature of the contamination and is working with Genzyme to identify corrective actions to manage the situation.
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