FDA finds bits of steel, rubber in Genzyme drugs

Written by Staff and Wire Reports

Friday, 13 November 2009 12:57

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 $4.17, or 7.8 percent, to $49 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.

Genzyme did not return repeated calls for comment Friday.

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) told investors that Genzyme had notified their company that, in rare circumstances, it has detected foreign particles in some products filled at the Allston Landing facility.

To ensure that patients are not exposed to foreign particles during product administration, Genzyme has issued a "Dear Doctor" letter to all physicians treating patients with enzyme replacement products that it markets, including Aldurazyme.

The letter states that foreign particles have been found in some vials filled at Genzyme's Allston Landing facility and reminds physicians, as a preventive measure, to use a 0.2-0.22 micron filter during administration.

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