Heparin Syringes Recalled by Covidien Ltd.Mar 31, 2008 | Parker Waichman LLP
Covidien Ltd., is the latest company to recall a heparin product over concerns that the drug may contain a contaminant that could be responsible for causing hundreds of adverse reactions in patients in the US. Covidien said on Friday that its supplier, Scientific Protein Laboratories of Wisconsin, said two lots of Heparin Sodium USP active pharmaceutical ingredient it received might contain a heparin-like contaminant. As a result, Covidien said that it was recalling its prefilled syringes that contain heparin as a precaution, although the company's products have not been implicated in any of the reported adverse reactions.
Scientific Protein Laboratories also supplied contaminated ingredients to Baxter Healthcare, the company whose heparin has been linked to more than 700 serious reactions and possibly 19 deaths among patient in the US. In the US, Baxter first recalled 9 lots of heparin in January, after the drug was linked to serious, and sometimes fatal reactions in some patients. Those reported reactions to Baxter heparin included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. In February, Baxter expanded the heparin recall to include all of its heparin products, and suspended sales of its drug.
The Covidien heparin recall came just a week after another company, B. Braun Medical, initiated its own heparin recall as a precautionary measure, and American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter’ broader recall. Heparin sourced from China has also been recalled in German, France, Italy, Denmark and Japan, and the US Food & Drug Administration (FDA) is currently detaining all heparin imports to the US at their points of entry until they can be subjected to further testing.
Earlier this month, the FDA 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 procured the active ingredients for its heparin from Changzhou SPL, a Chinese facility partially owned by Scientific Protein Laboratories. Changzhou in turn buys its heparin from two companies, called consolidators, that gather crude heparin from workshops that make it from pig intestines. Many Chinese workshops that make crude heparin are unregulated family operations.
The FDA has yet to determined if the ingredient substitution was intentional, but 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. China has been the point of origin for many drug contamination and counterfeiting scandals. The news of heparin contamination came 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.
Recently, it appears that the Chinese have taken steps to crack down on heparin producers. On March 21, the Chinese State Food and Drug Administration issued an order in a notice its Web site requiring heparin producers to obtain the raw chemicals used to make the drug from registered suppliers. Raw heparin suppliers in that country are now 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 insisted that ensuring the quality of exported chemicals like heparin was the responsibility of importers and importing countries.