Heparin recalls have now spread to Europe, with France, Italy and Denmark being the latest countries to recall the blood thinner because of contamination issues. Like the heparin made by Baxter International in the US, regulators in Europe believe the drug has been contaminated with chondroitin sulfate. However, there have have been no reports of serious reactions or deaths to heparin in France, Italy or Denmark. Heparin made by Baxter has been linked to more than 700 adverse reactions and 19 deaths in the US.
Heparin is a vital drug used in surgery, dialysis, and for the bedridden. Other drugs thin blood, but their effects are not as quick or easily reversed. In the US, Baxter first recalled 9 lots of heparin in January, after the drug was linked to serious, and sometimes fatal reactions in some patients. Those reported reactions to Baxter heparin included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. In February, Baxter expanded the heparin recall to include all of its heparin products, and suspended sales of its drug. Last week, B. Braun Medical initiated its own heparin recall as a precautionary measure, and American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter’ broader recall. Baxter manufactures about half of all multiple-dose heparin vials sold in the US, while B. Braun Medical supplies 10%-15% of the U.S. supply of injectable heparin. Despite the massive heparin recalls, US regulators have said that there is no shortage of heparin. (more…)