Louisiana Accident Attorney Blog

How has the chemical known as Chondroitin Sulfate gotten into some batches of the blood thinner heparin associated with 19 deaths?

U. S. health officials now are aware that the contamination is a man-made chemical compound known as over-sulfated chondroiton sulfate.

This is less expensive than heparin and is a natural compound that occurs widely and is normally used as a dietary supplement. The over-sulfated version has not been extensively studied.

According to Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation & Research, the Associated Press reported that "Right now, people should not be alarmed. We have not received any more reports of fatalities of this type since the recall on Feb. 28. We cannot rule in or out whether this was accidentally or deliberately introduced into the product. We are investigating how it go in."

Preliminary testing did not identify chrondroitin sulfate because it mimics heparin. It is less costly to produce than heparin, but the FDA officials could not estimate a cost difference.

Senator Edward M. Kennedy (D. - Mass) is quoted as saying, "it is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering. Whether this contaminant was introduced intentionally or by accident, the full force of the law must be brought to bear to bring those responsible to justice. To guard against future abuses, every drug manufacturer needs to inform the FDA of where it sources its ingredients and what it is doing to ensure that these ingredients are pure and potent."

Tests are being done, according to the FDA, to determine if heparin when combined with over-sulfated chronroitin sulfate can produce serious allergic reactions like those reported to Baxter and the FDA.

Heparin is used to prevent blood clots in millions of people with heart conditions, kidney disease and in surgery. It's made from ingredients extracted from pig intestines. Of all the heparin samples tested by the FDA, between 2 and 50 percent was made up of the contaminant. This does not assert that this was counterfeited on purpose.

To date, there have been 785 reported allergic reactions associated with Baxter's heparin. This compares to less than 100 in 2007.

Also, there have been 46 deaths among heparin users.

Baxter recalled all its heparin products following these announcements. APP Pharmaceuticals, Inc., the other major heparin supplier ramped up production to avoid a drug shortage after the recall by Baxter. Tests on APP's have not turned up any contaminants.