Canada not affected by recall of blood-thinning product

A blood-thinning product recalled by its U.S. manufacturer after hundreds of users reported adverse reactions was not distributed in Canada, a spokesman for Health Canada said Friday.

Baxter International Inc., based in Deerfield, Ill., announced last week that it's moving ahead with a full-scale recall of its heparin product.

On Thursday, the Food and Drug Administration said it had detected a "contaminant" in many samples of Chinese-supplied heparin that may be the cause of the allergic reactions to the blood-thinner, derived from an enzyme found in the mucous lining of pig intestines.

Chief medical officer Janet Woodcock said the agency is investigating whether the presence of the contaminant, a large molecule similar to heparin, was the result of faulty manufacturing or was intentionally added to reduce costs.

Baxter recalled nine lots of the injectable drug last month after learning of allergic-style reactions among dialysis patients. The problems included dizziness, difficulty breathing, nausea and a racing heartbeat.

Nineteen deaths in the U.S. have been associated with the recalled product, the FDA said.

"The recall will not impact Canada," said Health Canada spokesperson Paul Duschene. "The heparin in Canada is different. It does not have the same ingredients."

Lan Lai-Minh, director of corporate communications of Baxter Canada, said none of the vials recalled is sold in Canada. She said the company makes pre-mixed heparin solution bags in Alliston, Ont., for the Canadian market.

Meanwhile, Germany's medical authority said on Friday it has recalled a locally produced version of heparin believed to be linked to contaminated ingredients from China.

The drug, produced by RotexMedica GmbH, was pulled from the market Wednesday night after 80 patients suffered shortness of breath, low blood pressure and episodes of an overly rapid heartbeat.