Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Foreign particle contamination of several products used to treat rare, serious and life-threatening diseases has prompted a warning by the Food and Drug Administration (FDA). The warning includes products made by Genzyme and marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme and Thyrogen – used to treat serious conditions such as Gaucher Disease and thyroid cancer. The foreign particles found in the medications 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.

Last week, the FDA issued a recall on Hospira-made anesthetic propofol after particles of stainless steel were found in several lots of the drug causing a risk of serious adverse events.

Potential adverse events from IM administration of a contaminated product could include local pain, swelling and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. It is also possible that the foreign particles could affect how well these products work.

The FDA says it is “acutely aware” of the critical need for patients to have continued access to the recalled products. Thus, the agency has decided to allow these products to continue to be marketed. The FDA says it has carefully considered the potential for serious adverse events, the likelihood that the recommendations in its notice will significantly reduce the risk of administration of contaminated products, and the lack of FDA-approved therapeutic alternatives for the products. The agency is also actively investigating the nature of the contamination and seeking immediate implementation of corrective actions.

This entry was posted on Friday, November 20th, 2009 at 7:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.