What: Counterfeit heparin has been linked to the deaths of 81 people and resulted in hundreds of allergic reactions in the United States.
Batches of contaminated heparin were also detected in 11 other countries – resulting in as many as 68 more deaths. Reports issued by the U.S. Food and Drug Administration (FDA) concluded that the contaminated ingredient used to make heparin was imported from China.
When: Reports span from January 2008–May 2008.
Where: Reported cases have come predominately from the United States and Germany. The FDA also reported cases in Canada, France, Italy, the Netherlands, Denmark, Australia, New Zealand, Japan and China.
How: The contaminated product was distributed by Baxter International. Scientific Protein Laboratories (SPL) and its Changzhou SPL plant in Changzhou City, China, was Baxter’s main supplier of the active ingredient in heparin.
Heparin is an anticoagulant used to treat blood clots in the veins, arteries and lungs and is also used before certain types of surgery and in kidney patients before they undergo dialysis.
The U.S. FDA reports that it learned of the contamination on January 9, 2008, from CDC investigators who were evaluating “small clusters” of events in dialysis centers. The first recall was initiated on January 17, 2008. The FDA also reported that the drug was contaminated with oversulfated chrondroitin sulfate, a compound that mimics heparin and thus was not detected in routine testing. According to reports, in some samples of Baxter’s active ingredient, the contaminant made up between two percent and 50 percent of the total material.
According to the International Chamber of Commerce (citing the New York Times), the FDA discovered the contaminated heparin at Changzhou SPL, which bought heparin from two consolidators. These consolidators obtain “crude heparin from workshops” that make the drug using pig intestines. Many of these workshops are unregulated and family-run operations.
On February 19, The Washington Post published an admission by the FDA, stating that the Chinese facility that supplied the active ingredient in heparin was never inspected by the agency because it had confused its name with another just like it.
Since March 10, 2008, the FDA reports that it has been screening and reviewing all imported heparin products.
Baxter President Robert Parkinson told the House Subcommittee on Oversight and Investigations in April 2008, “We’re alarmed that one of our products was used in what appears to have been a deliberate scheme to adulterate life-saving medication.” Parkinson also said “the complexity of the global drug supply chain creates new and emerging risks that call for new ways of thinking about it, identifying and addressing vulnerabilities, and that resting on old standards—even ones that have worked for decades—is no longer enough.”
In April 2008, the chief executive for SPL told the House Subcommittee on Oversight and Investigations that the heparin contamination was “an insidious act” that “seems to us an intentional act upstream in the supply chain.”
Dr. Janet Woodcock, director of the FDA’s drug center, told the House Subcommittee on Oversight and Investigations in April 2008 that, “FDA’s working hypothesis is that this was intentional contamination, but this is not yet proven.”
Related cases and incidents:
In December 2007, the U.S. FDA recalled a shipment of pre-filled heparin syringes (Heparin Lock Flush Solution USP), found to be contaminated with Serratia marcescens which resulted in patient infections. The recalled product was distributed nationwide.
On February 25, 2009, two men pleaded guilty in U.S. District Court in Raleigh, NC, for ignoring sterility standards at the former AM2PAT Inc. Plant. They were awarded with relatively light sentences in exchange for information about CEO Dushyant Patel, whose company sold $6.9 million worth of heparin and saline syringes in 2006-2007 that did not undergo proper sterility testing, which lead to bacterial infections in 200-300 patients.
“Heparin Probe Focuses On One Contaminant,” CBS News. March 5, 2008.
“Scientists Near Source of Altered Heparin,” New York Times. March 19, 2008.
“FDA Identifies Contaminant in Heparin Batches,” Wall Street Journal. March 20, 2008.
“Heparin probe reveals global drug market perils,” CNBC. April 13, 2008.
“Scientists Unravel Heparin Death Mystery,” Science Daily. April 24, 2008.
“Heparin Contamination May Have Been Deliberate,” New York Times, April 30, 2008.
“As families recall deaths, FDA investigates deliberate heparin contamination,” Canadian Broadcast Corporation. May 1, 2008.
“Information on Heparin,” U.S. FDA. Updated June 2008.
“Heparin’s Deadly Side Effects,” TIME Magazine. November 13, 2008.