Chinese plant under scanner for Heparin problems

FDA is inspecting a Chinese plant to see whether this plant is a source of the problems in the Baxter International's heparin. Baxter had announced that it is temporarily stopping the production of its commonly used blood thinner, heparin after four deaths were linked to it.

It has been found that the Chinese plant was never checked and it could be the source of the problem. According to the Baxter spokeswoman Erin Gardiner, Baxter buys the active ingredient for the drug heparin from a supplier that manufactures it both at the Chinese factory and in the U.S.

The FDA said it was trying to determine why the Chinese plant under investigation was not inspected before it was allowed to ship the active ingredient in heparin to a Baxter-owned plant where the drug is finally furnished.

"Preparations are being made to perform an inspection as soon as possible," said Karen Riley, Food and Drug Administration spokeswoman. “We will be inspecting these facilities as soon as possible” she added pointing to the Chinese and the New Jersey facilities of the company.

Heparin is commonly used in dialysis to prevent clotting of the blood when it circulates in a dialysis machine. It makes the blood thinner and thus reduces the loss of the blood during dialysis. Anemic patients can’t afford this blood loss as it could prove fatal for them.

The first problem was reported last year when four children who were undergoing dialysis developed an allergic reaction when this drug was injected in them.

After that FDA investigators found that a total of 350 reports of patients’ were reported to have experienced problems difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure after being injected with large doses of heparin.

China is the world's largest supplier of active pharmaceutical ingredients, but export safety has become an increasing problem, with reports of Chinese-made toys and food being linked to contaminants. Some statistics show that Chinese exports of heparin and its components totaled $57.8 million in the first half of 2007, a 13.7% increase from the last year.

Erin Gardiner did not exactly mention the source but said that the supplier had been manufacturing heparin for more than 30 years and had been supplying Baxter for more than 20 years. She said the plant in China had been in operation for several years.

In January, Baxter had voluntarily recalled nine lots of its injectable heparin sodium injection in 1,000-unit vials, after reports of adverse reactions. Baxter supplies about half the heparin used in U.S. which generates annual revenue of $29 million for the company.