FDA Finds Bits Of Steel, Rubber In Genzyme Drugs

MATTHEW PERRONE

WASHINGTON (AP) — Federal health regulators have found tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues.

The 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.

Shares of Genzyme Corp. dropped $3.89, or 7.3 percent, to close at $49.28 Friday.

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