After more reports of serious side effects, the government urged American drugmakers and their suppliers yesterday to test Heparin products for a mysterious chemical that might have killed several users of the widely used blood thinner.
The Food and Drug Administration asked the handful of companies that make Heparin products or their main ingredient to conduct the sophisticated tests for the contaminant. The FDA made the request after authorities in Germany warned that Heparin made there was causing a spike in side effects and issued a recall.
Virtually all the Heparin products made by Baxter International Inc., of Deerfield, Ill., were recalled last month after hundreds of reports of serious side effects in the United States, including as many as 19 deaths.
American investigators discovered this week that the suspect products contained a chemical that looked like the key ingredient in Heparin during routine testing.
Investigators are trying to learn whether the chemical is a counterfeit added deliberately, either by suppliers in China or during processing in the United States.
The other leading Heparin maker, APP Pharmaceuticals of Schaumburg, Ill., has been testing its products for the contaminant and hasn't found it, FDA officials said.
The officials told reporters that they decided to ask all companies making Heparin, as well as their suppliers of its main ingredient, to perform the advanced tests after the German alert suggested contamination problems might extend beyond the Baxter products.
The German drug authorities told the FDA that they had received a spike in reports of serious side effects among dialysis and other patients. The patients had taken Heparin made by a German company, Rotexmedica GmbH Arzneimittelwerk, according to FDA officials.
Adding to concerns, FDA officials said, was the fact that the German drug maker's supplier was different from Baxter's supplier, Scientific Protein Laboratories of Waunakee, Wis.
Scientific Protein Laboratories got the Heparin ingredient now under investigation from a joint venture in Changzhou, China, adding to concerns about the safety of Chinese-made products.
SPL, which has recalled all of its tainted supplies, emphasized that the copycat ingredient might not have caused the side effects and the investigation is continuing.
FDA officials referred further questions to German authorities. The German Embassy didn't know about the recall, and Rotexmedica did not respond immediately to a request for comment.
jonathan.rockoff@baltsun.com