ENOXAPARIN the latest victim of the heparin debacle

THE CASE
The Australian Therapeutic Goods Administration has just (22 April 2008) announced that five batches of enoxaparin, marketed as Clexane by Synthelabo, have failed the testing for the contaminant oversulphated chondroitin sulphate (OSCS). These batches have been recalled immediately.

Dalteparin, marketed as Fragmin by Pharmacia, is the only other low molecular weight heparin available in Australia. Fortunately it has been found to be clear of contamination.

This Australian testing has been a reaction to the concerns first raised in the United States after the American drug company Baxter discovered there was a problem with it's heparin, and announced a recall on 17/01/2008, and the FDA issued a warning advisory on 11/02/2008.

The problem is thought to stem from one ore more Chinese heparin manufacturing plants, it was found that some batches of heparin contained up to 20% of OSCS when tested. This contaminant may have been deliberately introduced to bulk out the quantity of heparin - some assay tests for heparin also react to OSCS.

We are still facing a worldwide shortage of heparin, and various authorities should seriously consider shepherding unaffected batches of Clexane and heparinised saline, as well as all batches of Fragmin and heparin. This would be a sensible precaution until supply is stabilised.

MY VERDICT
Medical companies should always rigorously test any raw materials they use. They should not rely on the testing performed by the supplier. There are a lot of greedy people out there who do not care about the consequence of their actions.