Wednesday, February 13, 2008

Chinese Factory of Heparin Ingredient to be Investigated in Wake of Deaths

On Monday, Baxter (International) announced that it had temporarily suspended production of heparin because of about 350 reactions potentially tied to the drug, including four fatalities, primarily in patients undergoing kidney dialysis and heart surgery. An FDA official estimated that around 40% of the bad reactions potentially linked to the drug were classified as serious. Patients' reactions have ranged from stomach pain to vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting.

Heparin, which is derived from pig intestines, has been sold in the U.S. since the 1930s. Baxter had been selling the product at a rate of about 100,000 vials a day. Given either intravenously or by injection, the drug is used in a wide range of medical procedures to treat or prevent clotting. In particular, it is essential during procedures like cardiac surgery, in which a patient's blood is removed from the body. It is also used in kidney dialysis and in apheresis, a procedure used for some patients with immune-system disorders in which blood is taken outside the patient's body and some components of it are removed.

A Baxter spokeswoman confirmed that the company gets the active pharmaceutical ingredient for its heparin from a U.S. supplier that operates a plant in China and another in the U.S., but she declined to identify the supplier. She said that Baxter, in cooperation with the FDA, plans to inspect the Chinese factory, but she declined to say when.


Girish Malhotra said...

If Baxter International was getting their active ingredient from the plant in China then it means that they had not put in place the necessary safe guards in place knowing all along that any oversight in quality would be devastating.

Yes the Chinese company is to blame that they did not follow strict quality control specifications and let the stuff that was marginally out of spec pass through.

I lay the blame solely on Baxter International that they did not have proper controls. It is s critical product. I would recommend that Baxter be barred from selling and getting any product from China in US.

toothdigger said...

Thanks for your astute observation: I must agree that it sounds like Baxter International is to blame - unfortunately my understanding is that it also obtains the same ingredient from a plant in the U.S. Presumably the plant in the U.S. has higher standards??