Baxter stops Heparin production after deaths

Baxter International Inc has temporarily stopped the production of its famous and commonly used blood thinner, heparin after four deaths were linked to it.

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. The incident happened at a hospital in Missouri.

The most common reactions that are developed are difficulty in breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure. All these can prove fatal and thus further analysis was done on the effect of this drug.

The FDA investigators found that a total of 350 reports of patients’ were reported to have experienced problems after being injected with large doses of heparin, manufactured by Baxter Healthcare. Most of these cases have been reported in the last two months with almost 40 percent of these being serious. A total of 100 cases had been reported in the rest of 2007.

It was observed that adverse events were not seen in patients who received lower doses of the drug or who received higher doses spread over a longer period of time.

In January, Baxter had voluntarily recalled nine lots of its injectable heparin sodium injection in 1,000-unit vials, after reports of adverse reactions. But now that the reports of adverse reactions have been received from multi-dose vials of 1,000 units, 5,000 units and 10,000 units, the company has decided to stop the production for some time.

"We're doing an exhaustive investigation," Baxter spokeswoman Erin Gardiner said, "but at this point we really don't have a cause identified."

Baxter has also refused to recall any more of its stock and said it will continue to distribute the products to assure adequate supply in the market.

Some doctors also think that if the supply of the drug is too less then it could lead to increasing the risk to the lives of the patients who need heparin therapy in order to survive.

“It’s an essential part of dialysis treatment,” said Dr. Jay Wish, professor of medicine at Case Western Reserve.

Doctors have recommended the use of lesser dosage and alternative drugs in order to ensure that there are lesser cases of allergic reactions due to this drug.

Baxter supplies about half the heparin used in U.S. Heparin generates about $29 million in annual revenue for Baxter, less than 1 percent of the company's total revenue.

Baxter's shares were up 16 cents to $60.81 on the New York Stock Exchange.