Heparin News
FDA fears heparin tainted on purpose
-Boston Globe
04/16/2008 - US regulators suspect that Baxter International Inc.'s blood thinner heparin, linked to deaths and allergic reactions, was intentionally contaminated to increase profit.
Andrew von Eschenbach, the commissioner of the Food and Drug Administration, made the comment about heparin yesterday at a Senate hearing. He didn't specify who added the contaminant, and Baxter has said it appears to have happened before the product reached the company's supplier.
Some samples of Baxter's heparin, whose main ingredient was made from pig intestines and imported from China, were contaminated with a cheaper substance derived from animal cartilage, Baxter and the FDA said last month. Regulators said at the time they were uncertain whether the contamination was intentional.
"It was apparently, we suspect, done by virtue of economic fraud," von Eschenbach yesterday told a Senate Appropriations subcommittee that oversees FDA spending.
After the hearing, von Eschenbach said his comments may have gone too far. He told reporters the agency had no evidence the contamination was intentional.
"One thing you always wonder about is whether it was done in order to be deceptive," he said.
Sixty-two people given heparin died since January 2007 after suffering allergic reactions or low blood pressure, the FDA said this month.
Deerfield, Ill.-based Baxter, which sold about half the heparin in the United States, announced a recall in January this year. Heparin's uses include preventing blood clots during dialysis and heart surgery.
The FDA hasn't concluded where in the supply chain the tainted material was introduced. Baxter and its supplier of raw heparin, Scientific Protein Laboratories Inc., say the contaminant wasn't added in their factories. Baxter has been seeking access to consolidators and workshops in China that handled the crude material before it went to Scientific Protein.
Baxter hasn't determined how or why the contaminant was added, said spokeswoman Erin Gardiner yesterday. Scientific Protein doesn't know whether supplies were intentionally contaminated, said spokesman Wayne Pines.
However, a spokesperson for Baxter said it counts only four deaths possibly linked to its recalled heparin, adding that as yet, "there are zero patient deaths known to have been caused by the allergic-type reaction" as detailed in the FDA's tally.
Since the contamination scare emerged, a number of other companies across serveral countries have also been linked to contaminated lots of heparin via a Chinese supply chain, triggering a series of product recalls across the globe, although no deaths have yet been associated as a result.
Meanwhile, the FDA has also now sent a letter to drug device manufacturers warning them to examine the sources of the heparin used in their products, as some drug devices, particularly vascular stents and other devices used in pulmonary bypass, as well as in-vitro diagnostic procedures, are coated with a small amount of heparin, which is a blood thinning agent.
One such device manufacturer is taking no chances - Coviden already recalled its prefilled lock flush syringes containing heparin from the US market at the end of March as a precautionary measure.
The FDA has yet to determine how and where the contaminant entered the heparin supply chain in China, which is now the largest supplier of raw heparin ingredients in the world.
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