Genzyme Issues Letters to U.S. Healthcare Providers
Date: November 13, 2009
Genzyme Corp. (Nasdaq: GENZ) announced today that it has issued letters to U.S. healthcare providers regarding its enzyme replacement products Cerezyme® (imiglucerase for injection), Fabrazyme® (agalsidase beta), Myozyme® (alglucosidase alfa), Aldurazyme® (laronidase), as well as Thyrogen® (thyrotropin alfa for injection), filled at its Allston Landing manufacturing facility. The letters remind providers of the U.S. product labeling recommendations advising both visual inspection of vials and in-line filtration of enzyme replacement products to address the potential presence of foreign particles.
The safety profile of these products remains unchanged. A review of the global safety database for these products has not identified any safety concerns to suggest that patients treated with Genzyme products have been exposed to foreign particles. However, a theoretical safety risk remains should a particle enter the bloodstream.
Genzyme's quality control processes have detected foreign particles in these products at a rate of approximately 1 percent. The company's rate has not increased over time.
The global rate of product returns from customers due to the observance of foreign particles is less than approximately 0.02 percent for these products. Genzyme remains committed to reducing the frequency of foreign particles in all of our products.
The healthcare provider letters are available on the company's product websites.