FDA identifies trash in vials of drug used to treat enzyme disorders

2009-11-14 21:35:02 (GMT) (Caymanmama.com - Health News News)

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Genzyme building

Savannah, Georgia (CaymanMama.com) — Health regulators of the Food and Drug Administration have identified small particles of trash and debris from steel, rubber and fiber in drugs made by biotechnology firm Genzyme.

Genzyme is a drug used to treat rare enzyme disorders and the FDA said the particles of trash could cause serious adverse health effects for patients.

Following the FDA’s findings, shares of Genzyme Corp. dipped $3.12, or 5.9 percent, to $50.05 in afternoon trading.

According to the Associated Press, “The FDA announcement is the second case of contamination for the Cambridge, Mass.-based company this year. In June, Genzyme was forced to shut down a key production facility due to viral contamination.”

The other pharmaceuticals affected by the FDA announcement include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen.

The FDA is not removing the drugs from the market on the basis that few alternative treatments exist. It was recommended that physicians closely inspect the vials to Genzyme prior to injecting their patients with the drug.



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