OTTAWA - The following is to update Canadians on the recall of contaminated lots of heparin products from B. Braun Medical Inc., and the ongoing testing of the heparin supply in Canada.
The presence of a contaminan nt in the active pharmaceutical ingredients of certain lots of B. Braun heparin products was first identified by Health Canada and communicated to Canadians on March 20, 2008. This contamin ant has been found in the following specific products and lots, which are being recalled:
Lot number: J7D580, J6N438, J6J492, J5P643
Description: Heparin Sodium 20,000 units in 5 % Dextrose Injection, 500 mL
Drug Identification Number (DIN): 02209713
Lot number: J7E577 J6L669 J5S669
Description: Heparin Sodium 25,000 units in 5% Dextrose Injection, 500 mL
Drug Identification Number (DIN): 01935941
Lot number: J7E420, J6K645, J6H487
Description: Heparin Sodium 25,000 units i n 5% Dextrose Injection, 250 mL
Drug Identification Number (DIN): 02209721
Lot number: J7D485, J7C477, J6L453, J6K639, J6K567, J6J613, J6H716, J6H630, J6B493, J6A679, J6A422, J5N567
Description: Heparin Sodium 1,000 units in 0.9% Sodium Chloride Injection USP, 500 mL
Drug Identification Number (DIN): 01935933
In the majority of cases, these products are administered by intrav enous injection in a hospital setting. Even if patients have not had an allergic or other adverse reaction to the contaminated heparin, they may still be at increased risk of clotting because the product has not worked as expected. Patients should consult their physician or pharmacist if they are concerned they have been given products from these lots or if they experience an adverse reaction to any heparin product. Patients should not stop use of heparin without consulting a health care practitioner.
Health Canada has issued a Notice to Hospitals to ensure they are aware of the recall and to provide recommendations around the use of heparin products.
The contaminant found in the B. Braun products, oversulphated chondroitin sulph ate, has also been found in heparin products in other countries, including the United States and Australia.
A significant increase in allergic reactions related to heparin has been reported recently in the U.S. However, this increase has not been reported in Canada.
Health Canada has been in contact with all distributors and manufacturers of heparin products in Canada since March 11, 2008, when the department asked them to confirm that all lots currently sold in Canada have been tested and are free of the identified contaminants. Company results are due by this week. In the meantime, Health Canada has been testing samples from these companies, and may request additional samples to test as appropriate. Follow-up actions from the results of this testing will be communicated to Canadians as needed.
Heparin primarily acts as a blood thinner, preventing the formation of clots, and is used after surgery and in dialysis. Heparin is used when medically necessary after caref ul weighing of the risks and benefits for each patient. Patients should be monitored during and immediately following heparin administration for signs of allergy or anaphylactic reaction.
Consumers requiring more information about this Infor mation Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to heparin, please contact the Canada Vigilance Program of Health Canada by one of the f ollowing methods:
Toll-free telephone: 1-866-234-2345
Toll-free facsimile: 1-866-678-6789
Online at
www.healthcanada.gc.ca/mede ffect Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail:
CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect area of the He alth Canada Web site.
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Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
