Heparin contamination case goes global

The growing concerns over contaminated active ingredient in the blood-thinner heparin (Marketletters passim) has spread to Germany, according to reports in that country. The Federal Institute for Drugs and Medical Devices (BfArM) has contacted 10 German manufacturers of the drug to conduct tests to confirm the product's safety, the Wall Street Journal reports.

The federal regulator's action follows the revelation a week previously that heparin sold by Rotexmedica GmbH, a unit of France-based Groupe Panpharma, was recalled following allergic reactions by some patients.

The problem appears to be the same as that reported in the USA over Baxter International's heparin product, which exposed inspection failings by the US Food and Drug Administration as well as raising concerns over the monitoring of drug ingredients for export by China's State Food and Drug Administration (Marketletters passim). Although there are concerns over the quality of the raw material taken from pigs' intestines coming from China, no positive link between the suppliers and the adverse reactions has been found.