German Officials Recall Controversial Blood-thinning Drug
Posted on: Friday, 7 March 2008, 09:40 CST
The controversy over blood-thinning drug heparin got thicker as dialysis patients in Germany reported sickness after using a different brand of the product.On January 17, 2008 the drug’s distributor Baxter International voluntarily recalled heparin “as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production,” according to a press release.
However, Baxter was not named as the root of the recent problem in Germany.
FDA officials are experiencing difficulties locating the root cause of the contaminated compound.
Rotexmedica GmbH, the German company that makes their brand of heparin, uses a different supplier than Baxter International, thus adding length to the drug’s trail of contamination.
China is the world’s largest distributor of heparin, which is derived from pig intestines. It is often used in patients undergoing dialysis and heart surgery . Wisconsin-based company Scientific Protein Laboratories owns Changzhou SPL in China where it buys additional heparin from other Chinese suppliers. Baxter purchases its heparin from SPL.
About 80 percent of the active pharmaceutical ingredients come from foreign sources, according to U.S. government investigators. Baxter reported that most of these ingredients come from China.
Until news of the issue in Germany broke, SPL had been the on the receiving end of speculation that it might be the source of contamination.
"What is significant about the German recall is that the heparin active ingredient in their product was not obtained from SPL," or Scientific Protein Labs, Baxter's supplier, FDA Deputy Commissioner Janet Woodcock said.
The dilemma in Germany "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 Thursday.
The government organization has released a testing method to determine whether or not a batch contains the false ingredient.
"We're concerned about, worldwide, this contaminant in heparin and making sure it stays out of the heparin supply," the FDA's chief medical officer, Dr. Janet Woodcock, said. "With this testing method, there'll be a way to protect the heparin supply."
German authorities would not confirm that the product had been recalled.
“The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue,” said Peter J. Arduini, president of Baxter’s Medication Delivery business.
"Less than 100" severe reactions led to the recall in Germany, according to the FDA.
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Source: redOrbit Staff and Wire Reports
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