Canada has been drawn into the ever-widening scandal surrounding a commonly used blood thinner contaminated with a drug that can provoke life-threatening allergic reactions.
Health Canada said yesterday that testing had revealed that heparin products marketed in Canada by B. Braun Medical Inc. of Mississauga, Ont., were tainted.
The company immediately recalled its products in Canada, Australia and the United States.
Stephanie Euler, a spokeswoman for B. Braun, said 23 lots (of 25,000 units each) were being recalled. Three of those lots were distributed in Canada.
She said patients who have the product "should discontinue use immediately," but added that the product is used almost exclusively in hospitals.
Until now the contaminant, oversulphated chondroitin sulphate, had been found only in heparin manufactured by Baxter International Inc. Baxter does not sell those heparin products in Canada.
In the United States, 19 deaths and hundreds of cases of illness have been linked to the tainted heparin.
Health Canada declined to make an official available to discuss the issue. But in a statement, the department said it has received only one report of an allergic adverse reaction to heparin this year, and it is not clear whether that was related to the contaminant. The company said there have been no adverse reactions to the product and it is being recalled as a precaution.
B. Braun supplies about 10 to 15 per cent of the Canadian market in heparin, so the recall is unlikely to cause shortages. Health Canada said testing of heparin from other manufacturers is ongoing.
Heparin acts as a blood thinner, preventing the formation of clots that can trigger heart attacks or strokes. The drug, which is injectable, is used principally after surgery and in dialysis. (Patients with clotting problems may also use heparin occasionally, but generally take warfarin, an anti-clotting drug in pill form.)
The raw ingredient for heparin is derived from the mucosal tissues of slaughtered animals, specifically the intestines of pigs and the lungs of cattle.
In this case, the raw ingredient came from pigs in China, but it was doctored with chondroitin sulfate, a dietary supplement made from animal cartilage and used to treat joint pain. When chondroitin sulphate is altered, or "oversulphated," it mimics the blood-thinning action of heparin.
The U.S. Food and Drug Administration, which uncovered the contaminant, said it is unclear whether the doctored drug - which costs a fraction of what the real raw ingredient costs - was added deliberately or accidentally. What is clear is that it did not occur naturally or as a result of the manufacturing process.
Both B. Braun and Baxter have the same supplier of heparin in its raw form, the company Scientific Protein Laboratories LLC of Waunakee, Wis. It owns a company in China, Changzhou SPL, that purchases crude heparin from brokers who buy from family farmers. The doctoring of the drug appears to have been done by brokers.
In the wake of the scandal, the Chinese government has vowed to step up inspection of suppliers. China is one of the main sources of pharmaceutical ingredients in the world.
Health Canada does not inspect any overseas factories that produces drug ingredients.
Typical symptoms of the allergic reaction to heparin include low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain. The company said that any patient who experiences these symptoms after using heparin should immediately seek medical help.
André Picard