Certain Genzyme Products for Rare Disorders Potentially Contaminated With Foreign Matter

Emma Hitt, PhD

Disclosures

November 16, 2009

November 16, 2009 — Certain Genzyme products may be contaminated with stainless steel particles and other foreign matter, the US Food and Drug Administration (FDA) announced on Friday.

The products, including Cerezyme, Fabrazyme, Myozyme, and Thyrogen (each supplied as lyophilized powders), as well as Aldurazyme (a liquid solution), are used to treat rare, serious, and life-threatening diseases.

"The Agency is acutely aware of the critical need for patients to have continued access to these important products," according to an alert sent Friday from MedWatch, the FDA's safety information and adverse event reporting program. "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 foreign particles include stainless steel fragments, nonlatex rubber from the vial stopper, and fiber-like material from the manufacturing process, all of which could potentially cause serious adverse events in patients.

The FDA advises healthcare professionals to visually inspect products for particles before use and to "[c]ontinue to use an in-line, low protein-binding 0.2 or 0.22 micrometer filter as recommended in the drug labeling for Cerezyme, Fabrazyme, Myozyme, and Aldurazyme," although it is unknown whether such filtering will remove all foreign particles.

Potential adverse events from intramuscular administration could include local pain, swelling, and inflammation. Potential adverse reactions from intravenous administration of a product could include embolic events and anaphylactic, allergic, and immune-mediated reactions.

Cerezyme (imiglucerase for injection) is indicated for long-term enzyme replacement therapy in pediatric and adult patients with type 1 Gaucher disease that results in one or more of the following conditions: anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly. Fabrazyme is indicated for the treatment of Fabry disease. Myozyme (alglucosidase alfa) is indicated for use in infants with Pompe disease (GAA deficiency) to improve ventilator-free survival. Thyrogen (thyrotropin alfa for injection) is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer. It is also indicated for use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer. Aldurazyme is indicated for patients with Hurler and Hurler-Scheie forms of mucopolysaccharidosis 1 and for patients with the Scheie form who have moderate to severe symptoms to improve pulmonary function and walking capacity.

Contaminated products should be returned to Genzyme Corporation by calling 1-800-745-4447, option 2.

More information is available on the FDA's Web site.

Adverse events related to these products should be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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