FDA finds bits of steel, rubber in Genzyme drugs
Submitted by admin on November 16, 2009 – 1:20 pmNo Comment | 27 views
The San Francisco Chronicle reports that Food and Drug Administration said Friday that bits of steel, rubber and fiber found in vials of drugs used to treat rare enzyme disorders could cause serious adverse health effects for patients. Despite those problems, the FDA said the products would remain on the market, because there are few alternative treatments.
FDA regulators say doctors should closely inspect vials for particles before injecting them into patients. Doctors should return the product to Genzyme if they suspect contamination, the agency said. Physicians should also watch for potential allergic reactions, blood clots and other problems in patients.
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