FDA Warns of Genzyme Product Contamination

November 13, 2009

The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. 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.

The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. 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. The FDA is investigating the nature of the contamination.

This warning is the latest in a series of manufacturing problems at Genzyme. In June of this year, Genzyme was forced to halt production at its Allston Landing, MA, plant because of contamination with Vesivirus 2117 in several bioreactors, causing a major shortage in the drug Cerezyme. The plant has since resumed operations.

On February 27, Genzyme also received a complete response letter from the FDA regarding its application to market Lumizyme (also marketed as Myozyme) produced at the 2,000-L scale. In its letter, the agency outlined the remaining items that needed to be addressed before the application could be approved. To gain approval, Genzyme had to address issues identified in a warning letter that the company received simultaneous to the complete response letter. The decision to approve Lumizyme was expected to come through this weekend.

The FDA is aware of the critical need for patients to have continued access to these products, as was evidenced during the Cerezyme shortage. In making the decision to keep the products on the market, the FDA announcement said that the agency had "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." Several of these products treat orphan diseases for which there is currently no other drug on the market.

FDA Announcement