Heparin

Serious injuries and deaths have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, angio-edema, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.

FDA testing in January found that large amounts of Chinese raw heparin imported into the United Sates were contaminated with the chemical over-sulfated chondroitin sulfate. The FDA believes the substance was added to allow the product to pass tests that measure heparin levels.

A major heparin recall ensued. Almost 250 deaths and hundreds of severe allergic reactions were blamed on tainted batches of the blood thinner, which is frequently given to patients having heart surgery and kidney dialysis.

Two Celsus Laboratories products facing recall were heparin sodium and heparin lithium. The sodium form is given directly to patients as a blood thinner. Heparin lithium is used to coat medical devices, such as blood-collection tubes, to keep blood from clotting on them.

Changzhou SPL, a Chinese subsidiary of Scientific Protein Laboratories, was identified as the source of the contaminated heparin used by Baxter International, which bought heparin ingredients from SPL from 2004 through 2008 but did not inspect the facility until September 2007. The company sent one person who spent one day in the plant, five months later, the F.D.A. discovered myriad problems.

A Congressional investigator said the contaminant, over-sulfated chondroitin sulfate, cost $9 a pound compared with $900 a pound for heparin. Even with serious questions about products safety and contaminated ingredients imported from China , regulatory agency and local manufacturers continue to ignore consumer safety warning sign for ingredients and products made in China , allowing them to enter into the country without careful examination until tragedy happen.

The FDA has issued 13 recalls of tainted heparin products so far this year. Scientists are racing to develop safer, synthetic versions of the anticoagulant to reduce American dependence on China for the drug, which is traditionally made from a complex carbohydrate derived from pigs’ intestines.