Baxter International, Inc. has temporarily suspended production of heparin, a blood-thinner, due to reports of allergic reactions, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery. Heparin, a generic drug, is widely used in hospitals and dialysis centers. Baxter said it isn’t suspending sales of heparin that was already produced, a decision made in concert with FDA officials to avoid shortages. Baxter supplies about half of the heparin used in the U.S.
   
The company previously concluded that the reactions were confined to nine lots of the drug, which were recalled on January 17th, but now say the adverse reactions have spread beyond those lots and to a wider range of dosages. The product, derived from pig intestines, is made at the company’s Cherry Hill plant in NJ. An investigation has linked the active ingredient in the drug to Scientific Protein Laboratories of Waunakee, WI, which in turn obtains the ingredients from Changzhou SPL in Changzhou, China through a joint venture. Scientific Protein has been making the heparin active ingredient at the Chinese plant since 2004. The company said that it “engages in the same testing and quality-control procedures as U.S. facilities that produce bulk heparin and meets FDA standards.”
   
David G. Strunce, president of Scientific Protein, said that most of its active ingredient for heparin is made in China, but some comes from a Wisconsin factory. “There’s nothing that would explain these reactions, and we are very concerned about this,” he said. “We have no idea if these reactions have anything to do with our product.”
   
According to a statement by the FDA, it has never inspected the Chinese plant that makes Baxter’s heparin.