FDA probe seeks to find how blood thinner was tainted

FDA probe seeks to find how blood thinner was tainted

WASHINGTON (AP) — Some of Baxter International’s recalled blood thinner heparin contained large amounts of a contaminant that might explain hundreds of serious side effects. And the government said Wednesday it’s investigating whether what appears to be a fake ingredient got there by accident or by fraud.

The Food and Drug Administration said 19 deaths from allergic-type reactions are now associated with the recalled drug, up from four.

Baxter insisted the contaminant further points suspicion at ingredient suppliers in China, which are under increasing scrutiny after a wave of recalls involving food, drug and toy imports.

The FDA stopped short of ruling out a U.S. connection and cautioned that though 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 between 5 percent and 20 percent of some of the samples tested, what FDA 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 didn’t, because the contaminant is so chemically close to real heparin that standard testing couldn’t tell the difference, Woodcock said.