German heparin supplies recalled

Janet Woodcock, the deputy commissioner of The Food and Drugs Administration (FDA) has announced that 5 - 20 % of samples of the blood thinning agent , essential for people having dialysis, sold in the US by Baxter's was contaminated. (see previous posts)

There is , as yet, no direct causal link" between the drug and the 785 adverse reactions which have been reported so far. The number of recorded deaths has increased from 4 to 19. Nor can they say this was an "error , by some biological process, or if this occurred deliberately."

The FDA says the contaminant is present in the active pharmaceutical ingredient originating from Baxter's US supplier, Scientific Protein Laboratories of Waunakee, Wis. plant in China - who extract the basic product from pig intestines. However, the FDA said that it is also possible that the "heparin-like" substance could have been introduced at Scientific Protein's facility in Wisconsin. Baxter indicated that its New Jersey plant, which produces heparin in its final form, is not the cause of the problem.

The New York Times reports that the FDA have asked all U.S. companies that produce heparin to test it with nuclear magnetic resonance spectroscopy and capillary electrophoresis, the only tests that can uncover a possibly counterfeit ingredient.

German heparin product recalled.

Now Rotexmedica GmbH Arzneimittelwerk (owned since 1999 by Groupe Panpharma of Fougeres, France) has announced a product recall of its heparin product in Germany after receiving an increase in reports of adverse events (less than 100) in patients similiar to those recorded in the US but no deaths have been reported.

Axel Thiele, a spokesman for the Federal Institute for Drugs and Medical Devices, (BfArM) said the drug, was pulled from the market after 80 patients suffered shortness of breath, low blood pressure and episodes of rapid heartbeat. Press Release

Rotexmedica's heparin is made using an active ingredient from China, similar to Baxter's recalled product.

The company has written to doctors and pharmacists notifying them of the problem and claim "it can't be ruled out that the quality of the batches has been compromised."

The FDA state that heparin active ingredient used by Rotexmedica in their product was not obtained from" Scientific Protein Laboratories.

Scientific Protein may have obtained raw ingredients from the same source as the supplier for the German heparin, said Sidney Wolfe, director of Public Citizen's Health Research Group

In Switzerland the national medical authority Swissmedic is investigating heparin medication , but there have been no reports of complications.

How Heparin Maker in China Tackles Risks

This is the title of an article in the Wall Street Journal today about Shenzhen Hepalink Pharmaceutical Co.'s high-tech factory in the southern China boomtown of Shenzen who supply APP the competitors of Baxter in the US.

The Shenzhen Hepalink plant has been inspected and approved 9 times in recent years by government health authorities, including the U.S. Food and Drug Administration, China's drug watchdog and German regulators. Buyers have done their own audits 25 times.

Changzhou SPL the suppliers to SPL and thus to Baxters registered itself in China as a chemical manufacturer rather than a drug company. As such, it doesn't fall under the jurisdiction of China's State Food and Drug Agency. The U.S. FDA, in an oversight, also failed to inspect the facility when it began making the active ingredient for the U.S. market.

When FDA officials last month toured the Changzhou SPL factory at the center of Baxter's heparin recall, they described findings that indicated flaws in record-keeping and a lack of evidence that appropriate steps were being taken to effectively rid crude heparin of possible contaminants.

Baxter audited Changzhou SPL in September, Baxter spokeswoman Deborah Spak says. Baxter officials made "several observations," including "a few touching on the same areas" as those identified by the FDA.

Ms. Spak says Baxter approved the Changzhou SPL factory for heparin production "pending satisfactory responses" to the concerns its officials raised. Changzhou SPL provided those responses in January, she says, and Baxter continued to buy its heparin.

China's SFDA approved the two Chinese companies that made the active ingredient for the heparin now recalled in Germany: Changzhou Qianhong Bio-Pharma Co. and Yantai Dongcheng Biochemicals Co.

The U.S. and Europe stopped using heparin extracted from sheep and cow organs more than a decade ago after scientists became concerned about bovine spongiform encephalitis, or mad-cow disease, and the associated sheep disorder called scrapie.

This is a good article at the medical site Seeking Alpha Baxter's Recalled Heparin: The FDA Can't Keep Up - that details the problems the FDA have had in following up the production processes at Changzhou SPL suppliers to SPL > Baxters.

UPDATE 11th March 2008 10.00 pm GMT
Changzhou Qianhong Bio-pharma Co., Ltd. in Jiangsu province with total investment of RMB 120,000,000, covers an area of over 90,000 square meters with construction area of about 31000 square meters including comprehensive production building, office building, R&D center, and analysis and test center. The whole factory was designed and built according to national GMP standard. The company mainly produces lyophilized powder, injections, tablets, capsules and API etc. The annual production of preparations amounts to 1.2 billion pieces and that of API is 150tons. Typical products are Kallidinogenase, Elastase, L-Asparaginase, Urokinase, Heparin and LMM heparin and so on.

In business for 2 decades preparing Kallidinogenase, Elastase, L-Asparaginase, Multi-enzyme capsule etc. Especially we primarily use Kallidinogenase to cure chronic complications in diabetes.