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Genzyme's woes following the shutdown of its Allston manufacturing plant continue. The U.S. Food and Drug Administration is warning health-care professionals that five different Genzyme drugs may contain foreign substances that could potentially cause serious harm to patients.
Genzyme’s stock quickly dropped over 9 percent on the news, to $48.33, in noon trading Friday, down from the previous close of $53.17.
The foreign substances include stainless steel fragments, non-latex rubber from the 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 following products, which have the prefix “A” (e.g., Lot A12345): Cerezyme for Gaucher disease, Fabrazyme for Fabry disease, Myozyme for Pompe disease, Aldurazyme for Mucoploysaccharidosis Type 1, and Thyrogen, used as an adjunctive diagnostic tool and treatment for thyroid cancer.
Genzyme has received reports of customers discovering such foreign particles in vials of medicine. The 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.
All of the impacted drugs treat rare, life-threatening illnesses that have few or no currently marketed alternatives.
Adverse events from foreign particle contamination 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. Genzyme officials said that the adverse effects could range from minor to very serious, including respiratory failure.
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. Company officials said the finding of foreign particles is unrelated to the decontamination process that took place after the closure of the Allston plant. However, all five drugs were filled in the Allston plant and three drugs were manufactured there.
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