FDA detects contaminant in Baxter's blood-thinner heparin

The U.S. Food and Drug Administration said Wednesday that it has found a contaminant in some lots of the recalled blood-thinner heparin that had been linked to at least 19 deaths.

The federal health regulators said they detected a possibly counterfeit ingredient that mimicked the real drug in many samples of Chinese-supplied critical blood thinner Heparin, which is supplied by Scientific Protein Laboratories LLC of Waunakee, Wis. and sold by Baxter International Inc. (BAX).

The agency said a "significant" amount of a heparin-like substance is found in some recalled lots of heparin as well as in the so-called active pharmaceutical ingredient used in much of Baxter's heparin. However, the officials said they did not know what the contaminant was.

The American health watchdog is conducting the investigation to determine whether the presence of the contaminant, a large molecule similar to heparin, was the result of faulty manufacturing or was intentionally added to reduce costs.

Janet Woodcock, an FDA deputy commissioner and acting head of the agency's drug division said, "We don't know how this heparin-like compound got into the heparin. We don't know if this occurred by some error, by some biological process, or if this occurred deliberately, but we are aggressively investigating it."

Baxter International Inc., the world's largest manufacturer and distributor of hospital supplies and a leading provider of medical specialty products, announced late last month that it is voluntarily recalling nearly all remaining lots and doses of its heparin blood-thinning products.

The Deerfield, Illinois- based global healthcare company said it is expanding a recall of the blood-thinner heparin to include single-dose vials and HEP-LOCK heparin flush products.

Before that, in mid-January, Baxter had voluntarily recalled nine lots of multi-dose injectable heparin sodium injection in 1,000-unit vials, after reports of adverse reactions. But in the mid of this month the reports of adverse reactions had been received from multi-dose vials of 1,000 units, 5,000 units and 10,000 units, prompting the company to suspend the production for some time.

Baxter supplies nearly half the heparin used in U.S. Heparin generates about $29 million in annual revenue for Baxter, less than 1 percent of the company's total revenue. Heparin is commonly used in dialysis to prevent clotting of the blood when it circulates in a dialysis machine. It makes the blood thinner and thus reduces the loss of the blood during dialysis. Anemic patients can’t afford this blood loss as it could prove fatal for them.

The F.D.A. so far has received 785 reports of severe allergic reactions associated with the drug’s use, which include breathing difficulty, vomiting and rapid drops in blood pressure. Dr. Woodcock said though forty-six deaths have been reported to the agency, but only 19 of these appeared related to the suspect heparin.