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Friday, February 19, 2010

Contaminated Heparin Responsible For 81 Deaths

Heparin is a blood thinner given mostly to kidney dialysis patients, patients about to undergo by-pass surgery and those who are receiving critical care. The active ingredient in Heparin keeps patients from getting a fatal blood clot and is made from the lining in pig’s intestines.

Heparin has been used in hospitals and clinics in the US for over 70 years with few problems in it‘s history. However, during a 15 month period between November of 2007 and February of 2008, over 400 people suffered severe allergic reactions after receiving a Heparin injection and 81 of them have died.

Patients who suffered a reaction from the use of Heparin experienced severe low pressure, shortness of breath, abdominal symptoms, oral swelling, nausea, vomiting and sweating. Reactions were experienced within minutes of the injection and sometimes as late as an hour later. The FDA is uncertain at this time whether or not there will be long term side effects from these reactions.

Baxter International grossed $12.3 billion in sales globally and has manufacturing plants in 26 countries. Baxter purchases chemicals from a China based branch of Scientific Protein Laboratories to manufacture their Heparin products. It was this plant in China where a contaminant was found in the Heparin. The contaminant was found by the FDA to be Over-Sulfated Chondroitin Sulfate (OCS).

This substance appears to have a similar chemical structure to Heparin and it mimics it‘s blood thinning properties. OCS is made from pig cartilage and is much cheaper to make than it‘s pig intestinal counterpart. The OCS is difficult to detect without the use of sophisticated lab equipment and so it is unsure whether or not this contaminant was used accidentally or intentionally to save money.

The FDA admits that they did not inspect this plant in China because they got the name of the plant mixed up with another company. After the FDA traveled to China to inspect the plant, they found gross deficiencies in their procedures to remove impurities from the raw form of Heparin.

They also found some issues with waste material flow and overall manufacturing conditions. As a result, Baxter International eventually recalled all of its Heparin products including HEP-LOCK flushes used for IV devices, vacutainer blood collection tubes and as a coating for capillary tubes.

It is interesting to note that the FDA found some hospitals and clinics were still stocking the contaminated Heparin products in crash carts, pharmacies and their supply closets as late as three months after the recall.

More recent discoveries by the FDA have confirmed that two other Chinese plants were involved in the manufacture of the contaminated Heparin and the initial contact may have lied about these partners involvement.

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