Five Genzyme products for rare diseases found contaminated, but not a big danger
Vials of five drugs produced by Genzyme Corp. of Framingham, Mass., have been found to be contaminated with tiny particles of steel, rubber or fiber, the Food and Drug Administration said Friday. The drugs are not being recalled, but the agency and Genzyme warned physicians to check vials for such particles and to return any that they believe are contaminated.
Although the contaminants could theoretically damage blood vessels or trigger allergic reactions, the products are not being recalled because there are no alternatives to them. Some of them are also meant to be filtered before use, and all could be.
The five drugs are Cerezyme, used to treat Gaucher disease; Fabrazyme, for Fabry disease; Myozyme, for Pompe disease; Aldurazyme, for mucopolysaccharidosis; and Thyrogen, for thyroid cancer. About 1% of the vials are thought to be affected by the contamination, and no reports of adverse events have been received.
"We do not believe this is a wide-scale problem, but we do not have information that fully defines the scope," Dr. Jason Woo of the FDA said at a news conference.
This is the second episode of contamination affecting Genzyme this year. In July, a Boston-area plant was closed temporarily after inspectors found that lots of Cerezyme and Fabrazyme had been contaminated by a virus. Those products have been rationed since then, although the company said such rationing should end in the first quarter of 2010.
-- Thomas H. Maugh II