Unsolved Heparin Contamination Subject of Congressional Investigation

U.S. lawmakers are requesting a host of documents from a number of pharmaceutical companies in an attempt to track down the source of contamination in the blood thinner heparin, which is believed to have killed nearly 150 people three years ago. 

Although Baxter International, Inc. was forced to issue a heparin recall in 2008 for more than half of the supply of the blood thinner in the United States, no one culprit has been identified as having placed counterfeit ingredients into the raw ingredients for the medication.

FDA officials have said that it was most likely Chinese suppliers, who were attempting to cut corners, but a group of U.S. representatives say the country needs more than that.

On June 29, the U.S. House of Representatives Committee on Energy and Commerce sent letters (pdf) to a number of pharmaceutical companies who were involved in the production of the contaminated heparin, asking them to turn over any documents that may unveil where ingredients adulterated with the chemical overly sulfated chondroitin sulfate (OSCS) could have originated.

“There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S.,” the letter warns. “It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future.”

The letters were written to Amphastar Pharmaceuticals, APP Pharmaceuticals, Drug Source Company LLC , Global Pharma Sourcing LLC, Momenta Pharmaceuticals, Pacific Rainbow International, Sagent Pharmaceutical, Sandoz, Sanofi Aventis, and Siegfried USA, Inc. The companies were given until July 29 to respond.

The Baxter heparin recall was issued in January 2008, after a spike in adverse event reports surfaced involving serious and potentially life-threatening allergic reactions to the blood thinner, which is critical for a number of medical procedures and conditions. Hundreds of serious adverse reactions and nearly 150 deaths were reported in connection with the contaminated heparin.

The letter came just a couple weeks after the first heparin recall lawsuit resulted in a $625,000 award for the family of Steven Johnson, 63, who died in December 2007 after being given tainted heparin. It was the first case to go to trial in the United States out of about 300 heparin lawsuits consolidated in Cook County Circuit Court against Baxter and another ingredient supplier, Scientific Protein Laboratories, LLC.