Vials of 5 Genzyme Drugs for Rare Diseases May Be Tainted

Posted on November 21, 2009 in Health & Medicine

Vials of five Genzyme drugs for rare diseases may contain tiny particles of steel, rubber or fiber, the FDA announced Friday. The particle contamination could be potentially harmful to patients, although no injuries have been reported.

The drugs affected include Cerezyme for the treatment of Gaucher disease, Fabrazyme for Fabry disease, Myozyme for Pomp disease, Aldurazyme for mucopolysaccharidosis and Thyrogen for thyroid cancer.

All but thyroid cancer are rare enzyme deficiencies that affect only several thousand people in the world. The particles were traced back to the manufacturing process at the Boston factory, where the five drugs were put in vials. If patients took the drugs, the particles could damage blood vessels, block blood flow or prompt a severe allergic reaction.

The FDA and Genzyme decided against a recall because there are no other options for most of the drugs. Health authorities recommend using a filter to screen for particles when drugs are infused into a patient’s veins.