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Fake found in test of drug

The maker of heparin blames its Chinese suppliers, but the FDA isn't sure yet.

WASHINGTON - A recalled blood thinner made with active ingredients from China appears to have been contaminated by a mysterious lookalike substance, now the focus of an investigation into as many as 19 U.S. deaths and nearly 800 serious drug reactions, federal officials said Wednesday.

The government said it's investigating whether what appears to be a fake ingredient got into Baxter International's heparin by accident or by fraud.

Nineteen deaths from allergic-type reactions are now associated with the recalled drug, up from four, the Food and Drug Administration said.

Baxter insisted the contaminant further points suspicion at suppliers in China, which are under increasing scrutiny after a wave of recalls of foods, drugs and toys. The FDA stopped short of ruling out a U.S. connection and cautioned that while the contaminant is a prime suspect, officials haven't yet proved it harmed patients.

High-tech testing by Baxter and other groups uncovered a heparin-like compound in batches of the problem drug - a substance not found in batches of problem-free heparin.

The contaminant accounted for 5 percent to 20 percent of some of the samples tested, which the FDA drug chief, Dr. Janet Woodcock, called "significant quantities."

At those amounts, batches of heparin should have been flagged as subpotent in Baxter's routine quality tests - but they weren't, because the contaminant is so chemically close to real heparin that standard testing couldn't tell the difference, Woodcock said.

The FDA is so concerned that later this week it will give manufacturers and other regulatory agencies worldwide instructions on how to check other heparin supplies to be sure the contaminant isn't sneaking in. Remaining U.S. supplies of heparin, made by Baxter competitor APP Pharmaceuticals, do not show contamination, the FDA said.

Scientific Protein Laboratories, based in Waunakee, Wis., bought raw heparin produced in some cases in small, unregulated family workshops in China and processed it in plants in Wisconsin and China, according to heparin traders and producers in China. Baxter purchased the active ingredient from Scientific Protein and sold the finished drug.

Wayne Pines, a spokesman for Scientific Protein, said nothing sinister about the contamination had been proved. "No one really knows what happened here."

Information from the Los Angeles Times and New York Times was used in this report.

A tough trail

Heparin is derived from pig intestines, and the heparinlike contaminant is related to a complex group of chemicals also in those intestines, FDA officials said. That's part of the difficulty in determining how the contaminant got into bulk ingredients used to make vials of the injected blood thinner, which is used in patients undergoing dialysis and heart surgery.

[Last modified March 6, 2008, 00:59:06]