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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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