Follow-Up: China Factory Manufacturing Deadly Ingredient in Heparin Not Inspected

A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.

Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.

Baxter announced Monday that it was suspending sales of its multidose vials of heparin after 4 patients died and 350 suffered complications. Why the heparin caused these problems — and whether the active ingredient in the drug, derived from pig intestines, was responsible — has not been determined.

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.

Tainted Drug Paralyzes Leukemia Patients in China

A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.

Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China’s Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.

The drug maker, Shanghai Hualian, is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. It is made at a factory different from the one that produced the tainted cancer drugs, about an hour’s drive away.