Chinese Counterfeiters Suspected in Heparin ContaminationMar 20, 2008 | Parker Waichman LLP
It appears that heparin is the latest target of Chinese drug counterfeiters. Yesterday, the Food and Drug Administration (FDA) confirmed that it had determined that Baxter heparin had been tainted with an ingredient derived from animal cartilage. The substance, chondroitin sulfate, had been molecularly changed to mimic the blood clotting properties in heparin's active ingredient. Baxter sourced that active ingredient from China, which has seen a rash of drug counterfeiting scandals in the past year. Just today, the Chinese confirmed that the contaminant in the heparin did come from that country.
In the US, Baxter heparin has been linked to over 700 allergy type reactions and possibly 19 deaths. In Germany, there have been about 80 similar reactions to heparin made by another company, but no deaths. Baxter International began recalling heparin in January after the FDA received an unusually high number of adverse reaction reports linked to the drug. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening.
Baxter stopped selling multiple-dose heparin in early February, and the FDA advised doctors to prescribe alternatives. Baxter recalled all of its remaining heparin products on Feb. 29, after the FDA determined that other suppliers could make up for the lack of Baxter heparin. In early March, the FDA said its investigators found a contaminant in some batches of the active ingredient used in Baxter heparin. That ingredient is made by a Chinese facility, as well as a U.S. plant, both owned by Wisconsin-based Scientific Protein Laboratories LLC.
According to The New York Times, the FDA said it had found contaminated heparin at Changzhou SPL, the Chinese plant that supplies the active ingredient to Baxter. Changzhou in turn buys its heparin from two companies, called consolidators, that gather crude heparin 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.
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.