Fabrazyme FDA Alerts
The FDA Alerts below may be specifically about Fabrazyme or relate to a group or class of drugs which include Fabrazyme.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Fabrazyme
Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen
FDA and Genzyme 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. Cerezyme, Fabrazyme, Myozyme, and Thyrogen are supplied as lyophilized powders requiring reconstitution before administration; Aldurazyme is supplied as a liquid solution.
Potential adverse events from IM 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.
The Agency 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, FDA has carefully considered the potential for serious adverse events, the likelihood that 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.