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FDA Warns Device Makers on Heparin

Apr 14, 2008 | Parker Waichman LLP Concerns over tainted heparin have prompted the Food & Drug Administration (FDA) to warn medical device makers to examine the sources of the heparin used in their products.  According to the FDA, heparin tainted with a counterfeit ingredient has been implicated in at least 62 deaths, and 19 of those deaths may be linked to heparin made by Baxter International, the company that recalled most of its heparin products in the US earlier this year.

The Baxter heparin recalls came after the blood thinner was linked to hundreds of extreme - and in some cases fatal -  allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. Other manufactures have conducted similar recalls of heparin in Denmark, Italy, France Germany and Japan.  In the US, several other companies, including B. Braun, American Health Packaging and Covidien Ltd. announced precautionary recalls of heparin products

In March, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. However, the agency has not yet determined if the chondroitin sulfate was responsible for the deaths and reactions associated with heparin, although the chemical is the prime suspect.

Baxter gets some of that active ingredient from Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC. The FDA said it had found contaminated crude heparin at that plant. Changzhou buys its crude heparin from two companies, called consolidators, that gather it from workshops that make it from pig intestines. Many workshops that make crude heparin in China are unregulated family operations.

Since the contaminant was discovered, the FDA has been detaining all heparin imports at the border for testing before they are allowed into the US.  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.  

The FDA has yet to determine how and where the chondroitin sulfate entered the heparin supply chain in China, which is now the largest supplier of raw heparin ingredients in the world.

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