Tiny Particles of Trash Found in Genzyme Drugs

November 13, 2009

Washington - Tiny particles of trash including rubber, steel, and fiber were found in some drugs made by bio-tech Company, Genzyme, the US Food and Drug Administration (FDA) said on Friday.

Few months ago, health regulators also found bits of trash in some Genzyme drugs which are used to treat rare enzyme disorders.

In a statement, FDA officials said they have not yet announce a drug recall since there are only few alternative treatments in the market, adding that only 1 percent of the company’s products are affected by the contamination.

To prevent serious health effects which may be caused by some contaminated vials of drugs, health regulators advise doctors to closely inspect Genzyme’s drugs before injecting these to patients.

If doctors suspect that a medical product is contaminated, this should be immediately returned to the company, FDA said.

“Doctor’s should also watch for any signs of adverse reaction among patients such as blood clot and allergic reaction”, officials added.

According to previous reports, Genzyme was forced to shut down one of its facilities due to viral contamination last June.

Meanwhile, the Cambridge-based drugmaker said it has immediately notified doctors about the potential risk of its drugs but added there has been no reported case of medical complication caused by the products.

The affected drugs include Aldurazyme, Cerezyme, Fabrazyme, Myozyme, and Thyrogen which were all manufactured in Genzyme’s Allston Landing facility.