Baxter expands recall of its blood-thinner heparin

Baxter International Inc., the world's largest manufacturer and distributor of hospital supplies and a leading provider of medical specialty products, announced Thursday it is voluntarily recalling nearly all remaining lots and doses of its heparin blood-thinning products.

The Deerfield, Illinois- based global healthcare company said it is expanding a recall of the blood-thinner heparin to include single-dose vials and HEP-LOCK heparin flush products.

In mid-January, Baxter had voluntarily recalled nine lots of multi-dose injectable heparin sodium injection in 1,000-unit vials, after reports of adverse reactions. But in the mid of this month the reports of adverse reactions had been received from multi-dose vials of 1,000 units, 5,000 units and 10,000 units, prompting the company to suspend the production for some time.

However, Baxter at the time had refused to recall any more of its stock and had said it will continue to distribute the products to assure adequate supply in the market.

Now, as the U.S. regulators have concluded there is sufficient capacity of heparin from other suppliers, Baxter is moving ahead with a full-scale recall of its widely used blood-thinning product.

“We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs,” said Peter J. Arduini, President of Baxter’s Medication Delivery business. “The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of the increased rate of adverse reactions and resolve this issue.”

Baxter supplies nearly 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. 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.

More than 400 people have suffered severe allergic reactions, which include breathing difficulty, vomiting and rapid drops in blood pressure, and four patients who used it have died, the FDA said in January.

The US drug watchdog has admitted it never inspected a Chinese plant that supplies an active ingredient for Baxter's heparin before approving it because the Chinese plant mixed up the name with that of a different company.

The FDA said Thursday that it has completed the inspection of the Chinese plant but still had not determined the cause of the problem. "We're concerned about what we've observed but can't make links to the adverse events," said Michael Rogers, Director of the FDA's division of field investigations.