FDA finds bits of steel, rubber in Genzyme drugs

Nov 13, 2009
FILE - In this May 28, 2008 file photo, Genzyme's Manufacturing Facility is seen, in the Allston neighborhood of Boston. Federal health regulators said Friday, Nov. 13, 2009, they have found tiny particles of trash in drugs made by biotechnology firm Genzyme. (AP Photo/Bizuayehu Tesfaye, file)

(AP) -- Federal health regulators have found tiny particles of trash in drugs made by biotechnology firm Genzyme.

The 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.

Shares of Genzyme Corp. dropped $3.12, or 5.9 percent, to $50.05 in afternoon trading.

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.

Calls placed to Genzyme Friday afternoon were not immediately returned.

The drugs affected by the latest announcement include: Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen.

The FDA estimates the contamination only affects about 1 percent of Genzyme's products, and no adverse events have been reported to the government.

The agency is not removing the products from the market because it said there are few alternative treatments.

FDA regulators say doctors should closely inspect vials for particles before injecting them into patients.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: Anti-cholinergic drugs impair physical function in elderly patients

add to favorites email to friend print save as pdf

Related Stories

FDA: Arthritis drugs pose cancer risk to children

Aug 04, 2009

(AP) -- Federal regulators on Tuesday added stronger warnings to a group of best-selling drugs used to treat arthritis and other inflammatory diseases, saying they can increase the risk of cancer in children and adolescents.

FDA requires faster food safety reporting

Sep 08, 2009

(AP) -- Food makers will be required to alert government officials of potentially contaminated products within 24 hours under a new rule designed to help federal regulators spot food safety issues sooner.

FDA issues supplement rules

Jun 23, 2007

The U.S. Food and Drug Administration has issued new government standards for the manufacture of vitamins and dietary supplements.

Recommended for you

FDA to start regulating lab-developed tests

22 hours ago

(AP)—The Food and Drug Administration announced Thursday it will begin regulating laboratory-developed tests, a growing class of medical diagnostics that have never before been subject to federal oversight.

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

User comments : 0