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FDA Warns of Steel Particles in Genzyme Drugs

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Doctors should watch out for bits of steel, rubber and fiber in five drugs made by Genzyme Corp., the U.S. Food and Drug Administration warned Friday.

The FDA said contaminants were believed to be in less than 1 percent of the drugs, and that it had received no reports of adverse events, Dow Jones reported. The medicines are Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen.

The drugs, used to treat rare diseases, will remain on the market because few alternative treatments exist, the FDA said. In explaining the decision, the agency said it "carefully considered the potential for serious adverse events from foreign particle contamination," Dow Jones said. But the FDA said it is "acutely aware of the critical need for patients to have continued access to these important products."

Quality reports submitted by Genzyme alerted the FDA to the problem. Possible adverse effects could include damage to blood vessels or anaphylactic and allergic reactions, the agency said.

Medical personnel should carefully examine the products, which come in liquid and powder form, Dow Jones said

Anyone noticing a problem with drugs should call the agency at 1-800-FDA-1088, report problems via fax at 1-800-FDA-0178 or fill out a form online at: http://www.fda.gov/medwatch/report/hcp.htm.

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