Important Safety Information on HEPARIN - Notice to Hospitals

Starting date:

March 27, 2008

Posting date:

March 28, 2008

Type of communication:

Notice to Hospitals

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170001835

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on HEPARIN

March 27, 2008

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Pharmacy, Surgery, Emergency Medicine, Pediatrics, Geriatrics, Internal Medicine, Intensive Care, Nephrology and Dialysis Units and other involved professional staff and post this NOTICE in your institution.

Subject: Contaminant associated with serious allergic adverse reactions in the United States found in some Canadian HEPARIN products

As per the advisory posted on Health Canada MedEffect's website on March 20, 2008, Health Canada's testing of heparin has identified the presence of a substance similar to the contaminant, oversulphated chondroitin sulphate, identified by the FDA, in some lots of the active pharmaceutical ingredient of heparin from B. Braun Medical Inc. In the US, use of heparin products contaminated with oversulphated chondroitin sulphate has been associated with an increase in reported serious allergic and anaphylactic reactions and possible lack of effect. B.Braun is recalling the affected lots of unfractionated heparin for intravenous use on the Canadian market.

Health Canada testing of other heparin products available in Canada is ongoing. Health Canada is requiring all Canadian distributors and manufacturers of heparin to implement additional tests in all lots of heparin active pharmaceutical ingredient. Pending results, regulatory action will be taken as appropriate. Health Canada will continue to inform health care providers and the public as soon as new information becomes available, please monitor our website for updated information.

Health Canada is recommending the following:

• Ensure that the recalled lots of B. Braun Medical Inc's unfractionated heparin for IV injection are not used and are returned as instructed in the company's recall letter. Other unfractionated heparin products for IV use are available;
• Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired effect;
• Administer infusions without using a bolus dose whenever possible;
• Carefully monitor patients during and immediately following heparin administration for signs of allergy or anaphylactic reaction;
• Monitor anticoagulation parameters as the possible presence of a contaminant may affect the efficacy of the product;
• Ensure that this information is communicated accordingly if you are aware of any use of the above recalled products outside the hospital setting.

Background

On January 18, 2008, Baxter Healthcare and the U.S. FDA notified American healthcare professionals of a recall of all of their multi-dose and single-use vials of heparin, due to an increase in reports of allergic adverse reactions. The last reported number in U.S. is approximately 785 adverse reactions and 19 deaths associated with use of certain heparin lots in which the contaminant was found. FDA revealed that the contaminant is a substance called oversulfated chondroitin sulfate. However, the causality between the contaminant and the adverse reactions has not been established. Consult the US FDA.

Adverse reactions reported to Health Canada do not show an increase in allergic reactions related to heparin in 2007. In Canada, there was only one report of an allergic adverse reaction related to heparin from January 1, 2007 to March 6, 2008.

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of allergic/anaphylactic reactions or other serious and/or unexpected adverse reactions in patients receiving heparin should be reported immediately to Health Canada at the following address:

Any suspected adverse reaction can also be reported to:

Canada Vigilance Program

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

Ottawa, Ontario, K1A 0K9

Tel: 613-957-0337 or Fax: 613-957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866 234-2345 Fax: 866 678-6789

CanadaVigilance@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:

Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)

E-mail: bcans_enquiries@hc-sc.gc.ca

Telephone: 613-941-1499

Fax: 613-941-1668