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Posted: 5:01 PM Nov 13, 2009
FDA Finds Bits of Steel and Rubber in Genzyme Drugs
Federal health regulators say they have found tiny particles of trash in drugs made by biotechnology firm Genzyme.
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WASHINGTON (AP) - Federal health regulators say they have found tiny particles of trash in drugs made by biotechnology firm Genzyme.
The Food and Drug Administration says bits of steel, rubber and fiber in drug vials could cause serious adverse health effects for patients.
The drugs, which are used to treat rare enzyme disorders, include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen.
The FDA estimates the contamination only affects about 1 percent of Genzyme's products, and no adverse events have been reported to
the government.
The agency is not removing the products from the market because it says there are few alternative treatments.
The FDA says doctors should closely inspect vials for particles before injecting them into patients.
(Copyright 2009 by The Associated Press. All Rights Reserved.)
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