Last month, the questioned heparin was recalled and FDA reports that there have not been any new deaths since that time. The main ingredient from the blood thinner was imported from China.
Chondroitin is an ingredient found commonly in dietary supplements used as an alternative medicine to treat osteoarthritis and also approved and regulated as a symptomatic slow-acting drug for this disease. It is commonly sold together with glucosamine.
The over sulfated version of chondroitin has not been widely studied. The FDA is investigating if the compound was added to the heparin either accidentally or deliberately. The FDA started testing all imported heparin into the U.S. so that doctors and patients can use it safely.
Chondroitin sulfate is a compound that belongs in the same family like heparin that's why preliminary testing did not identify it. More exacting tests made by the government and some university researchers found the contaminant.
Over sulfated chondroitin sulfate is less expensive to make than heparin. "The base compound, chondroitin sulfate, is very abundant and an inexpensive compound," said Moheb Nasr, director of the agency's office of new drug quality and assessment. Chemically modifying it, Mr. Nasr added, "will not be that expensive either."
Baxter International Inc. recalled most of its heparin products last month after some were linked to hundreds of allergic reactions and several deaths. The recall has triggered a worldwide investigation and concerns about the safety and quality imports from China.
