Foreign Particles Found In Certain Products From Genzyme

Starting date:

November 25, 2009

Posting date:

November 25, 2009

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Contamination

Audience:

Healthcare Professionals

Identification number:

RA-110003181

• Media enquiries
• Public enquiries

Health Canada is informing health care professionals and Canadians that routine quality control testing has discovered foreign particles in a small number of vials of five products filled at a Genzyme Corporation facility in Boston. Genzyme has also received customer reports of foreign particles in some vials of these products. The particles observed include non-latex rubber originating from the vial stopper, stainless steel particles, and fiber-like material originating from the manufacturing process. The products involved are Cerezyme (the brand name for the drug imiglucerase), Fabrazyme (agalsidase beta), Myozyme (alglucosidase alfa), Aldurazyme (laronidase) and Thyrogen® (thyrotropin alfa).

Genzyme has reviewed all adverse events reported to them for these products and has found no evidence of patients having adverse reactions related to exposure to foreign particles.

Cerezyme, Fabrazyme, Myozyme and Aldurazyme are all used to treat rare, inherited diseases and are given by injection into the bloodstream. Potential adverse reactions from using an intravenous product contaminated with foreign particles include damage to blood vessels, blockage of small blood vessels, and anaphylactic, allergic or immune-mediated reactions. These reactions could be serious.

Thyrogen is sometimes used in the treatment of thyroid cancer and is injected into the muscle. Potential adverse events from injecting a product contaminated with foreign particles into a muscle could include local pain, swelling and inflammation.

Genzyme, in collaboration with Health Canada, has issued a letter to health care professionals and patient groups about the potential risks to patients and providing recommendations for physicians in the preparation and administration of these five products. Health Canada is working with the manufacturer to further investigate this issue.

Patients with questions or concerns about these products should speak to their health care professional.

Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at 613-957-2991, or call toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    Ottawa, ON K1A 0K9
    AL 0701C

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709