European Medicines Agency recalls heparin batches in France, Italy and Denmark

Concern is spreading in Europe about the extent of contamination of injectable heparin which has been sourced in China. To date the FDA have identified 19 deaths in the USA 19 patients who have died after taking heparin, apparently from allergic reactions.

London based European Medicines Agency spokesman Martin Harvey-Allchurch said that France, Italy and Denmark have recalled batches of the blood thinner heparin, although no adverse effects have been reported in any of those countries.

In Italy and Denmark, the raw material for heparin has been pulled from the market, while in Germany and France, it's the finished medicine that was removed, Harvey-Allchurch said. The ingredient has been traced to four Chinese manufacturers.

Germany's Rotexmedica GmbH said it recalled ``several batches'' of the blood thinner earlier this month after patients experienced allergic reactions. Switzerland's regulator asked G. Bichsel AG and B. Braun Medical AG last week to remove two heparin products from the Swiss market. German heparin supplies recalled (March 10th)

The EMEA presumes (but does not yet know definitely) that the contaminant in the three countries is over-sulphated chondroitin sulphate, the same substance found in lots of heparin recalled in the US and a deliberately modified form of the popular diet supplement for joint pains, chondroitin sulphate.

The Wall Street Journal reports that Italian company Opocrin SpA. said it bought some ingredients from Shenzhen Hepalink Pharmaceutical Co., in China that turned out to be contaminated.

APP Pharmaceuticals Inc. -- currently the sole supplier of large-dose heparin for surgery and kidney dialysis in the U.S. have also been supplied by the same company,

However APP spokeswoman Maili Bergman said yesterday that Opacrin heparin was sourced from a different slaughterhouse than the source of APP material. APP heparin has consistently tested contaminant-free in its own and in U.S. Food and Drug Administration testing.

Boston.com
iht
Previous posts on heparin contamination