Tainted Heparin May Have Been The Work Of Counterfeiters

The Chicago Tribune is reporting that tainted heparin that killed 19 people may have been the work of counterfeiters:

The U.S. Food and Drug Administration said today drug counterfeiters may have added a foreign ingredient into Chinese shipments of Baxter’s blood-thinner heparin which has been linked to 19 deaths and 800 illnesses.

As much as 25 percent of the material in the nine suspect lots of the blood-thinning drug, sold by Deerfield-based Baxter are a foreign substance that is similar in chemical make-up to heparin, said Dr. Janet Woodcock, acting director of the FDA’s center for drug evaluation and research.

Conventional quality and safety testing performed by Baxter and its supplier, Scientific Protein Laboratories of Waunakee, Wis., did not show any variation because the foreign substance is so similar to heparin. “It acts like heparin in this test, so it looks like everything is fine in the test,” Woodcock said.

The FDA is investigating where the substance came from and how it got into the heparin:

“We don’t know if this occurred by some error, by some biological process, or if this occurred deliberately,” said Woodcock.

The FDA said that the contaminant is present in the active pharmaceutical ingredient originating from Scientific Protein’s plant in Changzhou, China, but it also is possible that the foreign substance could have been introduced at the company’s Waunakee, Wis. plant or at Baxter’s Cherry Hill, N.J., processing facility.

Dr. Andrew C. von Eschenbach, commissioner of the FDA, declined to say whether or not the FDA actually inspects the facilities in China that produce pharmaceutical ingredients to the U.S., telling the paper: “I hope you’ll put this into a context that addresses the complexity of the problem.”

It you wanted an easy job, Doctor, why are you the commissioner of the FDA?

FDA finds contaminant in Baxter’s blood-thinner heparin [Chicago Tribune] (Thanks, Andrew!)