U.S. and China at loggerheads over contaminated Heparin

Apr 22 2008

Health officials in the U.S. appear to be at loggerheads with Chinese officials over the contamination of the blood-thinning drug Heparin.

According to the Food and Drug Administration (FDA) they have new evidence linking a contaminant to deaths and allergic reactions in patients who took the blood-thinner Heparin which were made with ingredients from China.

The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

Chinese officials have rejected the allegations and say that the chemical concerned was not the culprit.

The FDA says new data from research showed the contaminant, over-sulfated chondroitin sulfate, could trigger side effects such as those reported in the deaths of 81 Heparin patients.

In February this year drug company Baxter International was forced to recall most of its Heparin products made with ingredients from China following five deaths which were suspected to be linked to the chemical which originated from China.

Chinese officials maintain tests on batches of Heparin used by a patient who reported health problems, showed only some contained the contaminant.

The deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, Jin Shaohong says this shows that over-sulfated chondroitin can therefore not be the suspected cause of the Heparin linked adverse events.

However FDA officials insist they tested the Heparin in question and found the contaminant, and what is more ten other countries had also detected over-sulfated chondroitin sulfate in samples of Heparin made with Chinese ingredients; they are Australia, Canada, China, Denmark, France, Germany, Italy, Japan, The Netherlands, New Zealand.

The FDA says of all the contaminated Heparin found around the world, the one thing they have in common is China.

According to Chinese officials other contaminants could be to blame such as problems with the device used to inject the drug, or health factors with the patients who used the drug.

While Chinese investigators are calling for more information on the patients involved, Baxter has come down on the side of the FDA and says its own testing had also shown that over-sulfated chondroitin sulfate could cause the type of reactions reported in Heparin patients.

Baxter says the contaminant is the likely cause of the increased adverse reactions to the Heparin.

Heparin is made from pig intestines and is often collected from small and on the whole, unregulated farms in China; Baxter believes the contamination occurred before the product reached Baxter or its raw ingredient supplier.

An FDA investigation in both the United States and abroad included inspecting Baxter's domestic facilities, examining Heparin products in the United States and sending a team of experts to China to conduct a comprehensive inspection of the Changzhou SPL facility that makes the active ingredient for the drug.

The FDA says at this point it is unclear how the Heparin-like compound got into the Heparin Active Pharmaceutical Ingredient, but they are continuing to investigate the situation.

The FDA has issued a warning to the Chinese supplier of raw Heparin for Baxter, for failing to ensure its manufacturing process removes impurities.

The supplier Changzhou SPL says it will cooperate with the agency.

Allergic reactions, or low blood pressure, have also been reported after patients received Heparin, including Baxter's product.

The drug Heparin is used in kidney dialysis and various surgeries to prevent blood clots, and allergic reactions, or low blood pressure, have also been reported following patients receiving Heparin.

The FDA says that the Heparin currently sold in the United States was being tested and was safe and the recent increase in Heparin reactions were only reported in Germany and the United States.

The Heparin scare is just the latest in a succession of recalls involving products from China, including contaminated pet food, excessive lead in paint on toys and anti-freeze in toothpaste.

Health and Human Services Secretary Michael Leavitt says just sending inspectors to China and other countries will not be enough to make sure food and drugs are safe.

Leavitt suggests that independent certification may be the best solution and with that in mind the U.S. is considering setting up an office to strengthen oversight of food, drugs and devices imported from China.

Leavitt however believes that ultimately regulation will not be the answer and he has called for a new industry of global independent certification of farms, factories and other producers.