The FDA has sent a warning to biotech company Genzyme after particles of rubber, steel, and fibers were found in vials of five of their injectable medications. The contamination occurred during the manufacturing process, and the FDA is concerned because doctors could be, y’know, injecting garbage fragments into their patients.

The affected medications are for patients with relatively rare enzyme disorders.

Genzyme sent letters to healthcare providers reminding them that product labels advise visual inspection of the drug vials and filtration of Cerezyme, Fabrazyme, Myozyme and Aldurazyme to detect foreign particles.

Genzyme notified the FDA about the contaminated drugs through required product quality reports.

Potential health affects from injections of the contaminated products include pain, swelling and inflammation, the FDA said. Potential reactions from intravenous infusions of the affected products could be more serious, including damaged blood vessels, embolisms and allergic reactions.

The same plant that produced these contaminated products was briefly shut down earlier this year after products were contaminated with a virus. That incident raised questions about the company’s processes—this one will surely raise more.

FDA warns Genzyme [Boston Herald]
Genzyme virus exposes vulnerable plant processes [Reuters] (Thanks, Kyle!)

(Photo: kate at yr own risk)

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