Heparin probe highlights challenges of regulating global drugs market

From CBC News:
On a dusty lane in east China, a small factory sitting amid strawberry and vegetable fields processes chemicals from pig guts into heparin, a commonly used blood thinner linked to 62 deaths and hundreds of allergic reactions in the U.S. and Germany.

The mysterious problems with heparin from the factory and others like it - China's deadliest product quality scandal since Chinese cough syrup killed 93 people in Central America a year ago - dramatically illustrate the perils of shifting drug production offshore.

With recalls of heparin products now in six countries, it is an issue that regulators are scrambling to address. Some specific heparin products and certain lots from B. Braun Medical Inc. that were distributed in Canada are among those recalled in recent weeks. ...more

FDA cites 62 reports of possible heparin deaths

From Reuters:
U.S. regulators have received 62 reports of deaths during the last 15 months of patients who were treated with the blood-thinner heparin and suffered allergic reactions or low blood pressure, the Food and Drug Administration said on Tuesday.

Those are the problems that prompted Baxter International Inc to recall most of its heparin products in February. ...more

Further Details on Recall of Contaminated Heparin

From Health Canada:
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 contaminant 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 contaminant has been found in the following specific products and lots, which are being recalled ...more

Company kept heparin on market during tests

From the Globe and Mail:
A drug company continued to market its heparin products in Canada even though it knew its supplier was implicated in a growing scandal involving tainted ingredients that have been linked to 19 deaths and hundreds of illnesses in the United States.

B. Braun Medical Inc. announced a recall of its heparin products in Canada, the United States and Australia last Friday, after tests confirmed some products were contaminated with an ingredient also found in heparin products recalled a month ago by Baxter International Inc., which is now the subject of a major U.S. investigation.

Baxter purchased the contaminated ingredients from Scientific Protein Laboratories LLC, a Wisconsin-based company that has a factory in China. B. Braun Medical also buys its heparin ingredients from SPL, but didn't issue a recall until tests confirmed the contamination, weeks after the supplier's ingredients were first called into question. ...more

Germany recalls locally made blood thinner heparin; Canadian products differ

From the Canadian Press:
Germany's medical authority said Friday it has recalled a locally produced version of the blood thinner heparin believed to be linked to contaminated ingredients from China after 80 patients suffered adverse reactions.

Axel Thiele, a spokesman for the Federal Institute for Drugs and Medical Devices, said the drug, produced by RotexMedica GmbH, was pulled from the market after 80 patients suffered shortness of breath, low blood pressure and episodes of rapid heartbeat.

No one taking the drug in Germany has died, he said, and no other drug companies' products are involved.

A different brand of heparin produced in the United States has been linked to 19 deaths there, the U.S. Food and Drug Administration has reported.

On Friday, Health Canada said the U.S. deaths are associated with injectable heparin sodium made by Baxter International Inc., and these products are not sold in Canada. ...more