Genzyme Drug Contamination: Foreign Particles may be in Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen
The FDA has warned healthcare professionals that several important drugs manufactured by Genzyme Corp., which are used to treat rare and life-threatening diseases, may contain particles of steel, rubber and other contaminants. The foreign particles could be present in some vials of Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen; however the agency has decided not to recall the Genzyme drugs because they are in short supply and desperately needed by sufferers of several serious diseases.
Information about the potential Genzyme drug contamination was released by FDA on Friday, indicating that federal inspectors suspect that less than 1% of the products are likely to be contaminated. The particles include stainless steel fragments, non-latex rubber from vial stoppers and fiber-like material from the manufacturing process.
Although no reports of injury have been associated with the contaminated drugs, patients injected with drugs contaminated with foreign particles could experience potentially serious side effects. Symptoms of problems could include local pain, swelling and inflammation. If the particles get into the blood stream, they could also cause blood clots, pulmonary embolisms, anaphylactic shock and damage to blood vessels.
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A Genzyme drug recall was not issued because the FDA fears that removing the drugs from the market would result in a shortage of medication for people suffering from the rare illnesses the drugs are used to treat.
Cerezyme (imiglucerase) is used for the treatment of Gaucher disease. Fabrazyme (agalsidase beta) is used to treat Fabry disease. Myozyme (alglucosidase alpha) is used to treat patients with Pompe disease. Aldurazyme (laronidase) is used to treat Mucopolysaccharidosis Type I. Thyrogen (thyrotropin alpha) is a diagnostic tool and also used to treat thyroid cancer.
All of the drugs are given as intravenous (IV) infusions, except Thyrogen, which is an injection. Except for Aldurazyme, which comes as a liquid, all of the drugs are powders that are reconstituted before being given to patients.
There is already a shortage of Fabrazyme and Cerezyme, Genzyme’s best-selling product, because of viral contamination that led the company to temporarily shut down a plant in Boston this June. The drugs are not expected to be back to full supply levels until early next year.
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