Heparin illnesses spread to Germany

Concerns about the safety of the blood thinner heparin don't seem to stop anywhere instead they are getting worse day by day. Baxter International Inc.’s blood-thinner heparin that had been linked to at least 19 deaths in the United States is now linked to the dangerous allergic reactions in dialysis patients in Germany.

The U.S. Food and Drug Administration on Thursday said that German health officials have reported almost 100 cases of severe allergic reactions associated with a different brand of heparin. FDA said there have been no reported deaths in Germany.

FDA said that the dialysis patients in Germany experienced racing heartbeats and rapidly falling blood pressure after initial doses of a heparin blood thinner made by Rotexmedica GmbH Arzneimittelwerk in Trittau, Germany.

Following reports of severe reactions, the German health authorities recalled supplies of the blood thinner heparin, calling into question the safety and effectiveness of European supplies of the drug.

"What is significant about the German recall is that the heparin active ingredient in their product was not obtained from SPL," FDA Deputy Commissioner Janet Woodcock said. SPL or Scientific Protein Labs LLC of Waunakee, Wis. is Baxter's supplier.

"We're concerned about worldwide, this contaminant, in heparin and making sure it is safe, (and) out of the heparin supply," Woodcock continued.

The FDA on Wednesday 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).

German authorities have not yet tested the recalled heparin for the presence of a contaminant found in some recalled lots of heparin as well as in the so-called active pharmaceutical ingredient used in much of Baxter's heparin, Woodcock said.

Meanwhile, FDA is asking all US manufacturers that produce heparin to test it with two new procedures to make sure their products are free of contaminants.

Magnetic resonance spectroscopy and capillary electrophoresis are the two complex tests that can uncover whether the drug contains a possibly counterfeit ingredient.

Baxter International Inc., the world's largest manufacturer and distributor of hospital supplies and a leading provider of medical specialty products, 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.

Suspect lots of heparin are connected to at least four deaths reported across the country since the Deerfield, Illinois- based global healthcare company noted an increase in adverse reactions to the drug in late December.

The F.D.A. so far has received 785 reports of serious illness 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.