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Germany Recalls Heparin

Mar 11, 2008 | Parker Waichman LLP

Heparin has been recalled in Germany, for the same reason that Baxter Heparin was recalled in the US.  Germany's drug regulator, the Federal Institute for Drugs and Medical Devices, confirmed Friday it issued a recall for supplies of the blood thinner heparin after severe allergic reactions to the drug were reported; an additional warning for dialysis patients was also issued.  "We urgently suspect that they (the drugs) may be contaminated," said Axel Thiele from the German regulator on Friday.  Thiele also said Germany experienced about 80 cases of allergic reactions linked to heparin that included breathing problems, accelerated heart beat, and low blood pressure.

Baxter Pharmaceuticals’ heparin has been linked to 21 deaths and hundreds of severe reactions in the United States; the drug’s raw materials were imported from China.  The German heparin was 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.  Germany is the only European country reporting severe reactions to heparin, to date.

Late last month, the US Food and Drug Administration (FDA) reported that, since the end of 2007, it received about 350 reports of health problems associated with Baxter's multiple-dose injectable heparin; 40 percent were deemed serious and four resulted in death.  Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that—in some—was life threatening.  Baxter stopped selling multiple-dose Heparin vials earlier this month and the FDA advised doctors to prescribe alternatives.  Now, the FDA reports the number of possible deaths associated with heparin has risen to 21, the number of adverse reactions to 448, and they found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for Heparin; Baxter International, heparin’s manufacturer, announced it is expanding the recall to include most heparin products.

China is a massive producer of pigs and the largest supplier of the enzyme found in the mucous lining of the animal's intestines needed to produce heparin.  China, which exported heparin products to 42 countries and regions early 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.  China’s heparin market has been in turmoil over the last year as pig disease has swept the country, depleting stocks and leading some farmers to sell sick pigs into the market; some large companies have used small village workshops, which are often unsanitary and not inspected.

In the US, the FDA has not identified the cause of the heparin contamination and admitted this month it violated its own policy by failing to inspect the Chinese plant that manufactured the Baxter heparin prior to shipping the heparin ingredient to Baxter in 2004; China’s drug agency did not inspect the plant.  Last week, the agency sent inspectors to the plant and found a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment and, according to an inspection report released by the agency, the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.”


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