In a late afternoon update with reporters, Dr. Janet Woodcock, head of the FDA's office of drug safety, said the contaminant - over-sulfated chondroitin sulfate, or OSCS, has been found in heparin lots dating back to 2006. OSCS is a compound derived from animal cartilage that so closely mimics heparin that routine purity tests can't detect it.
Raw heparin is derived from pig intestines, often processed by small, unregistered workshops in China. Heparin is commonly used before certain types of surgery to prevent dangerous blood clots. Kidney patients also take it before undergoing dialysis.
The FDA told Action News today the contamination isn't limited to Baxter International, but was found in heparin products from many companies, and in 11 countries. The agency says there is no indication of the contaminant at the Baxter processing plant in Cherry Hill, New Jersey, but that it was found in the raw heparin.
The raw ingredient for Baxter International's recalled heparin came from Wisconsin-based Scientific Protein Laboratories, which in turn owns a Chinese factory - Changzhou SPL - and buys additional raw heparin from other Chinese suppliers.
The FDA released a warning letter to Changzhou SPL Co., hours after Chinese officials voiced doubts that a contaminant identified in the blood thinner heparin caused severe allergic reactions in hundreds of U.S. patients.
The FDA told Changzhou SPL that it had "significant deviations" from good manufacturing processes. Until it complies, the agency will recommend disapproval of any new applications listing the company as the manufacturer of any active pharmaceutical ingredient. The company said it regretted FDA's decision and that it did not believe the warning letter reflected Changzhou SPL's actual state of compliance with good manufacturing practices. At an embassy news conference, Chinese officials said the problems linked to heparin could have occurred in the United States, or that chronic conditions in some patients led to severe reactions. They plan to visit a Baxter International plant in Cherry Hill, N.J., to get a better picture of heparin's development. They also hope to take back some samples for their investigation. "When you see it, then you believe it," said Jin Shaohong, the deputy director general for the National Institute for the Control of Pharmaceutical and Biological Products in China.
Germany also discovered the contaminant and recalled batches of heparin after some patient illnesses
. But the Chinese officials contended Monday that batches not containing the contaminant - called oversulfated chondroitin - also have been associated with side effects. "The oversulfated chondroitin can therefore not be a suspected root cause of heparin adverse events as reported in U.S. media previously," Shaohong said. Baxter denied that claim. "We do not agree with that," said Baxter spokeswoman Erin Gardiner. "We have seen adverse event reports on batches where the contaminant has been confirmed to be present." Baxter was considering the Chinese officials' request for additional heparin samples for their own further testing, Gardiner said. The officials also noted that the implicated Chinese factory - Changzhou SPL - was managed and overseen by a manager from its U.S. headquarters. The heparin ingredient produced by the factory has all been exported. "None has been sold into the Chinese domestic market," Shaohong said.The FDA has announced plans to open 3 offices in China, to oversee processing of ingredients for the American pharmaceutical market. However, Chinese officials haven't decided whether to allow that, unless they can open similar offices in the United States.
