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The head of the U.S. Food and Drug Administration (FDA), Andrew von Eschenbach, said that he believes that the raw heparin supply to the United States may have been tainted due to economic fraud. The FDA has attributed 62 deaths to allergic reactions from raw heparin obtained from China.

FDA comments

Eschenbach told an Senate Appropriations Committees agricultural subcommittee that he believes the contaminated heparin supply to the United States contained oversulfated chondrotin sulfate, an altered version of chondrotin sulfate made from animal cartilage often found in dietary supplements. He claims that economic fraud may have been involved as the altered version is similar to the active ingredient in heparin, but less expensive to produce. The raw ingredient in heparin is derived from pig intestines.

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The Food and Drug Administration said Monday that contaminated heparin, a blood thinner, has been detected in 11 countries and that the number of U.S. deaths potentially linked to the contamination has risen to 81, up from 62.

The contamination is "a worldwide problem," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. U.S. supplies currently in circulation have been tested and are safe, she added.

The contaminated raw product that went into the heparin came from 12 companies, all located in China, the FDA says. The affected countries are Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

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An FDA investigation in both the United States and abroad included inspecting Baxter's domestic facilities, examining Heparin products in the United States and sending a team of experts to China to conduct a comprehensive inspection of the Changzhou SPL facility that makes the active ingredient for the drug.

The FDA says at this point it is unclear how the Heparin-like compound got into the Heparin Active Pharmaceutical Ingredient, but they are continuing to investigate the situation.

The FDA has issued a warning to the Chinese supplier of raw Heparin for Baxter, for failing to ensure its manufacturing process removes impurities.

The supplier Changzhou SPL says it will cooperate with the agency.

Allergic reactions, or low blood pressure, have also been reported after patients received Heparin, including Baxter's product.

The drug Heparin is used in kidney dialysis and various surgeries to prevent blood clots, and allergic reactions, or low blood pressure, have also been reported following patients receiving Heparin.

The FDA says that the Heparin currently sold in the United States was being tested and was safe and the recent increase in Heparin reactions were only reported in Germany and the United States.

The Heparin scare is just the latest in a succession of recalls involving products from China, including contaminated pet food, excessive lead in paint on toys and anti-freeze in toothpaste.

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Additional details about Baxter Healthcare Corporations, urgent recall of Heparin, a prescription injectable blood coagulant often used in hemodialysis (the filtering of blood) and cardiac invasive procedures, on January 25th 2008 are now being released. The Food and Drug Administration (FDA) has reported that it never inspected the Chinese manufacturing plant that provides Baxter with the active ingredient of the drug.

FDA admission

According to several news sources, the FDA, already under scrutiny for not adequately protecting the public against many harmful drugs and defective medical devices, admitted that it did not inspect the Chinese plant that provides Baxter with Heparins active ingredient an enzyme taken from pig intestines which has been linked to several adverse reactions to the drug.

The active ingredient is shipped to a Baxter facility in New Jersey where the final manufacturing process is completed. Baxter has reported that it inspected the plant outside of Shanghai, China less than months beforehand and that it plans to inspect it again based on this latest report.

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Background There is an urgent need to determine whether oversulfated chondroitin sulfate (OSCS), a compound contaminating heparin supplies worldwide, is the cause of the severe anaphylactoid reactions that have occurred after intravenous heparin administration in the United States and Germany.

Methods Heparin procured from the Food and Drug Administration, consisting of suspect lots of heparin associated with the clinical events as well as control lots of heparin, were screened in a blinded fashion both for the presence of OSCS and for any biologic activity that could potentially link the contaminant to the observed clinical adverse events. In vitro assays for the activation of the contact system and the complement cascade were performed. In addition, the ability of OSCS to recapitulate key clinical manifestations in vivo was tested in swine.

Results The OSCS found in contaminated lots of unfractionated heparin, as well as a synthetically generated OSCS reference standard, directly activated the kininkallikrein pathway in human plasma, which can lead to the generation of bradykinin, a potent vasoactive mediator. In addition, OSCS induced generation of C3a and C5a, potent anaphylatoxins derived from complement proteins. Activation of these two pathways was unexpectedly linked and dependent on fluid-phase activation of factor XII. Screening of plasma samples from various species indicated that swine and humans are sensitive to the effects of OSCS in a similar manner. OSCS-containing heparin and synthetically derived OSCS induced hypotension associated with kallikrein activation when administered by intravenous infusion in swine.

Conclusions Our results provide a scientific rationale for a potential biologic link between the presence of OSCS in suspect lots of heparin and the observed clinical adverse events. An assay to assess the amidolytic activity of kallikrein can supplement analytic tests to protect the heparin supply chain by screening for OSCS and other highly sulfated polysaccharide contaminants of heparin that can activate the contact system.

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F.D.A.s working hypothesis is that this was intentional contamination, but this is not yet proven, Dr. Janet Woodcock, director of the Food and Drug Administrations drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday.

A third of the material in some batches of the thinner heparin were contaminants, and it does strain ones credulity to suggest that might have been done accidentally, Dr. Woodcock said.

Two weeks ago, Food and Drug Commissioner Andrew C. von Eschenbach told a Senate subcommittee that the contamination was done by virtue of economic fraud, but he quickly withdrew the remark, saying he had probably gone too far.

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