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Drug Withdrawal

DW staff (sp)March 8, 2008

German authorities have confirmed they have recalled supplies of the blood thinner heparin because they suspect the products may be contaminated, widening a withdrawal of the drug linked to 19 deaths in the US.

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Patient receives vaccine
The injectable blood thinner is used to prevent and treat blood clotsImage: AP

Germany's drug regulator, the Federal Institute for Drugs and Medical Devices, confirmed on Friday it had issued a recall order for heparin after reports in February of severe allergic reactions to the drug and an additional warning for dialysis patients last week.

"We urgently suspect that they (the drugs) may be contaminated," Axel Thiele from the regulatory body said on Friday, March 7. He said some 80 cases of allergic reactions after consumption of the drug had been reported so far in Germany. They ranged from breathing problems, accelerated heart beat to low blood pressure.

The drugs were manufactured by RotexMedica, a subsidiary of the French company Groupe Panpharma. Health authorities in the northern German state of Schleswig-Holstein, where RotexMedica is located, issued the recall order to the company.

So far, Germany remains the only European country to register severe reactions to heparin.

Made in China link under scrutiny

Heparin, an injectable blood thinner given to prevent and treat blood clots, has caused a furor in the US in recent weeks ever since newspapers reported that at least 19 people have died there since they were treated with the drug. Heparin is derived from pig intestines. It is used in dialysis and heart procedures, among other surgeries, to avoid blood clots.

The deaths in the United States have been linked to heparin-based medications produced by Baxter Pharmaceuticals whose raw materials were imported from China.

A huge producer of pigs, China is the largest supplier of the enzyme found in the mucous lining of the animal's intestines that is needed to produce heparin. US investigators are now ratcheting up scrutiny of the supply chain.

China, which exported heparin products to 42 countries and regions in the first half of last year, exported the most -- about 13 tons -- to Germany, according to a report by the China Chamber of Commerce for Import and Export of Medicines and Health Products.