Report: Baxter Recalls All of Its Remaining Heparin Products

By Anna Boyd
11:37, February 29th 2008
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Report: Baxter Recalls All of Its Remaining Heparin Products

Baxter International Inc. said yesterday that it was recalling all of its remaining heparin products, now that officials at the Food and Drug Administration have concluded there is sufficient capacity from other suppliers.

“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,” Peter Arduini, president of Baxter’s medication delivery business, said in a statement, according to Reuters.

On February 11, Baxter, based in Deerfield, Ill., temporarily halted production of multidose vials after the FDA said it had received about 450 reports of health problems associated with Baxter’s injectable heparin product since the end of 2007.

The problems occurred primarily in patients undergoing kidney dialysis and heart surgery. Adverse reactions included difficulty breathing, nausea or vomiting, excessive sweating and falling blood pressure, which can lead to life-threatening shock. Four patients died, but the relationship to the drug was unclear.

“While we have reports of four deaths at this time, it is not possible to establish a relationship between the deaths and the use of heparin. To date, a cause to the adverse events has not been identified,” Dr. Jenkins, director of the U.S. FDA Office of New Drugs at the Center for Drug Evaluation and Research said at the time.

Meanwhile, a preliminary inspection by the FDA found that the Chinese plant responsible for the production of the controversial heparin (Changzhou SPL near Shanghai) had problems involving impurities, the quality, and use of its equipment, and overall quality control. A spokesperson for Baxter said the employees responsible have been disciplined, but could not confirm whether they are still with the company, the Chicago Tribune reported.

Baxter said it was recalling all if its remaining heparin products as a “precautionary step,” even though the vast majority of the reports of adverse reactions have been associated with the multidose form of the product. The heparin recall includes Hep-Lock heparin flush products but not premixed IV solution in bags, Baxter said.



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