Personal Injury Law

Heparin Recall Expands to Germany, 80 Sickened

By Jane Akre

Even though Germany does not use Baxter Healthcare's heparin, that has been the subject of a massive U.S. recall, that country's own locally produced version of the blood thinner has been recalled after 80 patients fell ill. 

Germany's heparin is produced by Rotex Medica GmbH. 

It was pulled from store shelves Wednesday night after German patients undergoing dialysis began having symptoms identical to Americans - shortness of breath, low blood pressure and a rapidly beating heart.

The source of the contamination is unknown at this time.

No one there has died, while 19 in the U.S. have. 

China is the leading source of heparin used by the U.S, India and Germany. Heparin is derived from the lining of pig intestines and sourced by local suppliers in China.

The  FDA would not disclose the supplier in a statement Thursday but it did rule out Scientific Protein Laboratories which helps produce Baxter's heparin using raw material from Chinese suppliers.

There are two version of heparin in Germany. One is inexpensive and less highly processed and that is the version that seems to be most affected while the more heavily processed form has not seen the same reactions.

Public Citizens Dr. Sidney Wolfe, director of the Health Research Group says the outsourcing of raw materials for import and the oversight by the FDA is an  "out of control" system and these results are not surprising.

The mysterious substance found in 20 percent of the U.S. suspect lots contain what the FDA calls a  "fake" ingredient, similar to heparin that raises suspicious of intentional tampering of the supply chain in China.  

In the U.S., the FDA is encouraging heparin manufacturers to begin using high-tech tests to identify whether their product has a mysterious contaminant that may be the source of the allergic reactions and death.    

Heparin is used in emergency rooms and on dialysis patients to reduce the chance of blood clots. 

So far in the U.S. besides the 19 deaths, there have been 785 allergic reactions to heparin reported to the FDA since January of 2007. #

Full post as published by InjuryBoard on March 07, 2008 (boomark / email).