FDA warns five Genzyme drugs contaminated

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Jule M. Donnelly

The Food and Drug Administration says that five different Genzyme drugs may contain foreign substances that could potentially cause serious harm to patients.

The affected products include Cerezyme for Gaucher disease, Fabrazyme for Fabry disease, Myozyme for Pompe disease, Aldurazyme for Mucoploysaccharidosis Type 1, and Thyrogen, which used as an adjunctive diagnostic tool and treatment for thyroid cancer. All of the drugs treat rare, life-threatening illnesses that have few or no currently marketed alternatives.

The substances include stainless-steel fragments, non-latex rubber from a vial stopper, and fiber-like material from the manufacturing process. The foreign particles are believed to be found in less than 1 percent of products based on product lots assessed to date, This problem affects all lots of the below listed products which have the prefix “A” — for example, Lot A12345.

Genzyme officials said all five of the drugs are filled at the Allston plant, which was closed for six weeks over the summer due to contamination by a virus. Three of the drugs are also manufactured there.

Genzyme’s stock dropped more than 9 percent on the news, to $48.33 in noon trading Friday, down from the previous close of $53.17.

FDA was alerted to contaminated vials through product quality reports, which are required to be submitted by the manufacturer, in compliance with FDA’s Current Good Manufacturing Practices. The FDA is actively investigating the nature of the contamination and seeking immediate implementation of corrective actions to mitigate the situation.

At this time, no adverse event reports attributed to foreign particle contamination have been received by FDA. Adverse effects 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, according to the FDA. It is also possible that the foreign particles could affect how well these products work.

The FDA has decided not to remove the products from the market because of the acute medical needs of these patients. There is already a shortage of Cerezyme and Fabrazyme, due to the six-week closure of the company’s plant in Allston this summer, after the discovery of contamination by a virus.

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