FDA Identifies Contaminant in Heparin API, Investigation Shifts to Source

-FDA News

03/21/2008 -  The impurity detected in the active pharmaceutical ingredient (API) used in Baxter’s recalled heparin products is a highly sulfated form of chondroitin sulfate, a chemical cheaper to manufacture than bulk heparin sodium, according to the FDA.

It took weeks of investigation to identify the chemical, CDER Director Janet Woodcock said during a Wednesday press conference. The substance is suspected of being the cause of serious adverse events and patient deaths associated with Baxter’s troubled heparin franchise, production of which has been suspended. Although the chemical was found in heparin lots linked to the adverse reactions, a causal association has not been confirmed.

“Chondroitin sulfate itself is a biologically derived compound that is commonly available,” Woodcock said. “However, over-sulfated chondroitin sulfate is not ordinarily found in nature. It is most likely that ordinary chondroitin sulfate was chemically modified to create this compound.”

When the FDA first announced that it had detected the previously unidentified impurity, it said the chemical made up 5 percent to 20 percent of certain API batches. Current tests reveal levels of the impurity ranging from 2 percent to 50 percent, Woodcock said.

“Now the contaminant has been identified, FDA can move forward to determine how and when in the supply chain this contaminant was introduced,” Woodcock said. “At the moment, we don’t know definitively whether the contaminant was introduced intentionally or by accident.”

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