By Justin Blum and Avram Goldstein
March 6 (Bloomberg) -- The blood-thinner heparin, linked to deaths in the U.S., has been recalled in Germany after patients there suffered allergic reactions, American regulators said.
The German heparin was made by Rotexmedica GmbH, not by Baxter International Inc., whose heparin distributed in the U.S. has been linked to deadly reactions, said Janet Woodcock, the Food and Drug Administration's chief medical officer, on a conference call with reporters today.
Regulators are trying to determine why versions of the drug made by different manufacturers with materials from different suppliers are causing allergic reactions, according to the FDA. The agency and Baxter said yesterday that deadly allergic reactions to heparin in the U.S. may have been caused by a fake ingredient from China.
A ``heparin-like molecule'' was found in Chinese-made crude heparin processed at the plants of Baxter's supplier, Scientific Protein Laboratories, in Changzhou, China, and in Wisconsin, where Scientific Protein is based, according to the FDA. The company didn't provide ingredients to Rotexmedica, the FDA said.
``We believe this demonstrates that the heparin problem is not within Changzhou SPL's or Baxter's manufacturing facilities, but our investigation into the root cause of the problem will continue,'' Scientific Protein Laboratories said in a statement.
Scientific Protein may have obtained raw ingredients from the same source as the supplier for the German heparin, said Sidney Wolfe, director of Public Citizen's Health Research Group, a Washington-based advocacy organization, in an interview.
`Out-of-Control' System
``Given how completely out-of-control the system is, nothing is surprising,'' Wolfe said of the drug industry's international supply chain. Suppliers in China are poorly regulated, said Wolfe, a frequent critic of the FDA.
Heparin, made from ingredients extracted from pig intestines, is used to prevent blood clots in millions of people with heart conditions, kidney disease and in surgery.
A phone call to Rotexmedica in Germany wasn't answered after normal business hours. Groupe Panpharma of Fougeres, France, acquired Rotexmedica GmbH, of Trittau, Germany, in 1999, according to Panpharma's Web site. Heparin is listed as a product.
Woodcock referred questions to German regulators about the country of origin of the main ingredient in the heparin recalled there. Ulrich Heier, a spokesman for the German government's institute for pharmaceutical and medical products, didn't answer a phone call after business hours.
No German Deaths
There were no reports of deaths in Germany, according to Woodcock, who said she didn't know how much heparin was recalled. Woodcock said there were fewer than 100 reports of harmful side effects in Germany, including a ``cluster'' of cases at a kidney dialysis center and other cases reported by doctors.
Manufacturers and suppliers of active ingredients for heparin should test their products using two different techniques to spot substances that shouldn't be in the drug, the FDA said. Descriptions of the tests, capillary electrophoresis and nuclear magnetic resonance spectroscopy, were posted on the FDA's Web site.
Those tests haven't yet been used on the German heparin to determine if that product has the same contaminant as the one in the U.S., said Karen Riley, a spokeswoman for the FDA.
`Outdated Testing'
Representative Rosa DeLauro, a Connecticut Democrat, criticized the FDA for failing previously to use the tests of the heparin ingredients now being recommended.
``This raises the question as to whether outdated testing methods are being utilized to test modern drugs,'' said DeLauro, who heads a subcommittee responsible for FDA budget appropriations. ``Clearly our drug safety efforts have not kept up with globalization or 21st Century medicine.''
Baxter began withdrawing multidose vials of heparin on Jan. 17 because of reported allergic reactions. The Deerfield, Illinois-based company expanded its recall on Feb. 28 to include all remaining vials. The FDA received 785 reports of side effects from all brands of heparin, including 19 deaths with symptoms of allergic reactions since January 2007.
Baxter fell 74 cents, or 1.3 percent, to $57.38 at 4:16 p.m. in New York Stock Exchange Composite trading.
To contact the reporters on this story: Justin Blum in Washington at [email protected]; Avram Goldstein in Washington at [email protected].
Last Updated: March 6, 2008 21:16 EST
posted by Kathy Kokotis