FDA finds trash particles in Genzyme's drugs, leading firm to advise health care providers

The US Food and Drug Administration has found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues.

Shares of Genzyme fell 7.3% to $49.28 at 4:01 p.m. New York time on the Nasdaq Stock Market on November 13, the biggest single-day decline since July 31. The firm's stock has declined 26% this year. Meantime, the share price of UK drugmaker Shire, which rushed its Gaucher disease drug velaglucerase alfa, to the US market on news of Genzyme's previous problems, jumped 1.4% to £11.48 on the latest development.

The FDA said last Friday that bits of steel, rubber and fiber found in vials of drugs used to treat rare enzyme disorders could cause serious adverse health effects for patients. Despite those problems, the agency said the products would remain on the market, because there are few alternative treatments.

As a result, Genzyme has issued letters to US health care 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 US product labeling recommendations advising both visual inspection of vials and in-line filtration of enzyme replacement products to address the potential .

The safety profile of these products remains unchanged, said Genzyme. 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, the firm noted.

Genzyme's quality control processes have detected foreign particles in these products at a rate of approximately 1%. 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% for these products. The health care provider letters are available on the company's product web sites.