November 14, 2009

The FDA Find Bits Of Trash In Genzyme Drugs

The FDA has found garbage floating around in vials of drugs made by Genzyme, the agency warned doctors today.

The FDA said on Friday that bits of steel and rubber were found in drugs made by Genzyme used to treat rare enzyme disorders, saying it could cause serious adverse health effects for patients.

The news sent Genzyme shares plunging 8% soon after the FDA posted a warning to doctors on its web site. The stock has since recovered somewhat and is now down 5% to $50.09.

The products will remain on the market, despite those problems, because there are few alternative treatments.

FDA regulators said doctors should return the product to Genzyme if they suspect contamination. Physicians should also watch for allergic reactions such as blood clots and other problems.

Shares of Genzyme Corp. dropped $4.17, or 7.8 percent, to $49 in afternoon trading.

The drugs affected include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen.

Dr Jason Woo, FDA's associate director of medical affairs, says, "We have worked continuously with Genzyme to ensure the continued availability of safe and effective products to meet the medical needs of  patients with rare medical disorders."

Genzyme specializes in biotech drugs to treat rare diseases.


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