Important Information on Changes to Heparin Potency

Important Information on Changes to Heparin Potency

2009-191

OTTAWA - Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent.

Heparin is a common anti-clotting drug mainly used in health care settings such as hospitals. It is used, for example, as part of kidney dialysis or to prevent blood clots. Most heparin products on the Canadian market use the same potency standard as is used in the U.S. As a result, the changes to the U.S standard will also affect heparin products available in Canada.

Given that heparin dosage and treatment is determined on a case-by-case basis using frequent blood testing, the change in potency is not expected to have a significant impact in most situations where heparin is used. However, there may be specific situations in a hospital setting that will require health care professionals to take this change in heparin potency under consideration, such as procedures where heparin is used as a single dose to achieve an immediate anti-clotting effect. In such procedures, blood monitoring may not necessarily occur.

When administering the drug, health care professionals should be aware of the potential difference in potency between heparin made under the old system and heparin made under the new system.

Patients requiring heparin may notice they are receiving a higher-than-usual dose or number of units of heparin because of the reduced potency of the product. As well, following a heparin treatment, patients may notice they are being monitored more than before. This monitoring may include blood testing that is commonly used to check heparin treatment, and will likely be temporary as the newer product replaces the old product on the market.

As in the U.S., there will be a transition period in Canada of approximately two years starting in December 2009 when products manufactured under both the old and new systems will be available at the same time. This is necessary to ensure that there is no heparin shortage and patients can continue to receive treatments as scheduled. Health Canada is currently working with manufacturers to ensure that heparin products using the new standard are clearly identified during this transition.

Health Canada issued a Notice to Hospitals on November 25, 2009 with more specific recommendations and information on when this transition will be implemented in Canada.
This document can be found on the Health Canada website.

Patients with questions or concerns about heparin 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 ProgramHealth CanadaAL 0701COttawa, ON K1A 0K9 To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the
Health Canada website.

Media Enquiries:Health Canada(613) 957-2983

Public Enquiries:(613) 957-29911-866 225-0709