New Heparin Regulations Announced by ChinaMar 21, 2008 | Parker Waichman LLP
China has placed tighter controls on heparin manufacturing following the discovery that heparin ingredients sourced from that country had been replaced with a substance derived from animal cartilage. Tainted heparin manufactured by Baxter International has been blamed for over 700 serious reactions and 19 deaths in the United States, while heparin made by another company has sickened at least 80 people in Germany.
Baxter recalled nearly all its heparin injections in the US after some patients experienced extreme allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls of Chinese-sourced heparin in Germany and Japan. Earlier this week, the US Food and Drug Administration (FDA) confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin's blood-clotting properties. However, the agency has not yet determined if the chondroitin sulfate was responsible to the deaths and reactions associated with Baxter heparin.
Baxter gets some of that active ingredient from Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. The FDA said it had found contaminated crude heparin at that plant. Changzhou buys its crude heparin from two companies, called consolidators, that gather it from workshops that make it from pig intestines. Many workshops that make crude heparin are unregulated family operations. Baxter has said that its investigators have not been able to get permission from the Chinese to visit these operations, and the FDA has not yet done inspections on any of these facilities either.
While the FDA maintains that it has not yet determined if the ingredient substitution was intentional, several sources told The New York Times that it was likely not accidental. Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
According to a report in The Wall Street Journal, the Chinese State Food and Drug Administration issued an order in a notice seen Friday on its Web site that requires heparin producers to obtain the raw chemicals used to make the drug from registered suppliers. Raw heparin suppliers, meanwhile, are required to improve their management and tests on their products, it said. This was a reversal of the Chinese government's earlier position, as the agency had earlier insisted that ensuring the quality of exported chemicals like heparin was the responsibility of importers and importing countries.
The news of heparin contamination comes almost one year after some pets in the US died as the result of a pet food ingredient shipped from China that contained toxic levels of melamine, which was added to make it appear higher in protein. In Panama around the same time, 120 people died because an unlicensed Chinese chemical plant sold a cheap counterfeit ingredient, diethylene glycol, that was mixed into cold medicine imported to that country. Diethylene glycol contamination also resulted in a recall of Chinese-made toothpaste in the US over the summer.