Patient beware: Contamination found in Genzyme drugs for rare disorders

According to a Food and Drug Administration report out today, five drugs made by Genzyme that are used for treating rare disorders were contaminated with metal and rubber particles that could pose serious risks to people who take them. The five drugs are:

• Aldurazyme (laronidase)
• Cerezyme (imiglucerase)
• Fabrazyme (agalsidase beta)
• Myozyme (alglucosidase alpha)
• Thyrogen (thyrotropin alpha)

These drugs are all used for treating mucopolysaccharidosis Type I, Gaucher disease, Fabry disease, Pompe disease, and thyroid cancer, respectively.

Potential side effects from these contaminated products include pain, swelling, and inflammation at the injection site, if they were given as shots. Intravenous administration could pose more serious adverse reactions, including blood clots, damage to blood vessels, and sudden, severe allergic reactions involving the whole body.

The FDA advised people who use these drugs to check their injection sites for redness, pain, discoloration, and hardness. Any breathing difficulties, rash, chest tightness, or unusual symptoms during or after treatment should be reported to your doctor. 

The FDA said it is allowing the products to remain on the market because people with the rare disorders they are used to treat have a critical need for them and there are no alternatives for four of the drugs.

The agency added that it is investigating how the products became contaminated with stainless steel fragments, rubber particles, and fiber-like material, as well as ways to prevent it from re-occurring.

—Steve Mitchell, associate editor, Consumer Reports Best Buy Drugs

Comments

[john bernabeu]

sounds exactly like a pump bearing seal disintegrated on a chemical batch used for all the drugs (maybe even a simple water pump)