Germany Asks Drug Firms to Test Heparin

-Wall Street Journal

03/12/2008 - Germany's medical regulator has asked companies selling the blood thinner heparin in Germany to test all batches of their product for contamination, the regulator said.

The Federal Institute for Drugs and Medical Devices, known by the German acronym BFARM, asked 10 manufacturers of the drug to carry out the additional tests yesterday and expects results soon, perhaps by next week, Ulrich Hagemann, a pharmaceutical-safety official at the agency, said in a phone interview. He said he couldn't name the companies for legal reasons but said all are German.

BFARM's move follows last week's recall in Germany of heparin made by Rotexmedica GmbH, a unit of the French company Groupe Panpharma. The product was recalled after reports that some patients taking it had allergic reactions.

The trouble in Germany follows safety worries in the U.S., where contaminated heparin supplied by Baxter International Inc. has been recalled.

The U.S. Food and Drug Administration has received reports of 19 deaths of patients who appear to have suffered allergic reactions after taking heparin. It isn't clear how many of them took the Baxter product.

Baxter has said that the contaminant in its drug was found in batches made from ingredients made in China. In a statement yesterday, Rotexmedica said that the active pharmaceutical ingredient, or API, from its recalled heparin also came from China.

"The supplier of the API is qualified and registered and the API used complies with the agreed specifications," Rotexmedica's statement said. But it added that "it has not been possible to exclude any possibility of a contamination with an unknown impurity."

Rotexmedica said it recalled three batches of heparin last week and has begun recalling 12 more batches made from the same API, "as a preventative action."

Dr. Hagemann said BFARM had asked all sellers of heparin in Germany to report whether they had purchased API in China. But the agency can't be sure the problem is related to China and has therefore ordered all heparin sellers to test their products for contamination, he said.

"We have to look: what are companies doing, what do they import, what do they use for production of their medicinal products?" he said.

The German regulator initially received about 80 reports of allergic reactions in people who took heparin at dialysis centers but has narrowed those down to about 30 cases, he said. Their reactions included rashes, a decrease in blood pressure, sweating and difficulty breathing, he said; none of the patients died.

Three of the cases occurred in people using the Rotexmedica product, he said. The German regulator isn't sure which companies made the heparin taken by the other patients, Dr. Hagemann said.

He said BFARM has been in frequent contact with the FDA.

Heparin is given by injection and intravenously to prevent blood clots.

The drug's raw ingredient is made from the intestines of pigs. China is a big supplier of the raw ingredient, which is often made by suppliers that get little regulatory oversight.

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