Tainted Heparin Shipped to U.S. by Two Chinese Firms, FDA ChargesApr 20, 2009 | Parker Waichman LLP
The Food & Drug Administration (FDA) has cited two Chinese manufacturers for shipping tainted heparin to the U.S. According to The Wall Street Journal, one of the firms has also been charged with lying to the FDA about its role in the contaminated heparin scandal.
In January 2008, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, after being administered the products. There were similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in 12 countries. In the US, the FDA ultimately initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
In March 2008, the FDA confirmed that it had found oversulfated 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. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. Chondroitin sulfate costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
According to The Wall Street Journal, the FDA has now charged that Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co. were involved in making and sending 19 lots of tainted heparin sodium to the U.S., which the agency discovered in April 2008. The tainted drug didn't reach any patients because the FDA stopped all the shipments at the border, the Journal said. The FDA said the heparin had been contaminated with oversulfated chondroitin sulfate.
The charges were included in letters the FDA sent to the firms following inspections conducted in July and August 2008. In its letter to Shanghai No. 1, the FDA also said it "uncovered untrue statements and information by your firm to the agency" relating to the actual maker of heparin.
The FDA letters said the firms have in the past supplied heparin to California-based Amphastar Pharmaceuticals Inc., and its subsidiary International Medication Systems Ltd. According to The Wall Street Journal, Amphastar makes pre-filled syringes and other products.
This is the first time the FDA has disclosed that Qingdao Jiulong and Shanghai No. 1 had been implicated in the tainted heparin scandal, the Journal said. At a Congressional hearing last March, the FDA would only identify Changzhou SPL, even though it had said at least 12 Chinese companies had been implicated.