The Wall Street Journal-20080212-Baxter Halts Production of Heparin
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Baxter Halts Production of Heparin
Full Text (714 words)Baxter International Inc. temporarily suspended production of the widely used blood-thinner heparin because of about 350 possible allergic reactions, including four deaths, primarily in patients undergoing kidney dialysis and heart surgery.
Because heparin, a generic drug available for decades, is widely used in hospitals and dialysis centers, Baxter said it isn't suspending sales of the heparin already produced. Officials of the Food and Drug Administration made that decision along with executives of Baxter, of Deerfield, Ill., to avoid shortages.
Baxter supplies about 50% of the heparin used in the U.S., so the possibility of a shortage arising is a real one. Although more than a week ago the company said it had concluded the reactions were confined to nine lots of heparin, it now said the adverse reactions have spread beyond those lots and to a wider range of dosages. The company, which has made the product at its Cherry Hill, N.J., plant since a 2003 acquisition, still isn't sure what caused the problem. Heparin is derived from pig intestines.
Leaving a possibly tainted product on the market required an agonizing balancing act by the FDA, and will mean more balancing by kidney specialists, heart doctors and others who use the product.
"In many of its uses, heparin is life-saving and life-sustaining," said John Jenkins, director of the FDA's office of new drugs. "We are facing a complex situation." Dr. Jenkins estimated 40% of the 350 adverse events were "characterized as serious," and said the agency will contact other suppliers, including foreign ones, to help meet a possible product shortfall. Baxter has been selling the product at a rate of about 100,000 vials a day.
Baxter began recalling the original nine lots Jan. 17. The FDA decided not to extend it beyond those lots. "A recall would result in an immediate and severe shortage," said Dr. Jenkins. However, such a shortage becomes a greater possibility the longer Baxter suspends manufacturing.
Heparin is given either intravenously or by injection. It has a wide range of uses, from surgery to dialysis to treating clots, and is used to prevent clots after fractures. "It is a mainstay of our therapy," said University of Chicago hematologist Joseph Baron. "It's used extensively in virtually all medical services."
"It potentially could become a critical issue as far as dialysis patients," said James L. Bailey, a nephrologist at Emory University in Atlanta. He noted many of the estimated 300,000 patients who get dialysis need to be placed on heparin. During dialysis, the patient's blood is cleansed by running it through tubes and a device called a dialyzer. Heparin is used to prevent clotting.
Other patients recently had bad heparin reactions while undergoing a procedure called apheresis. Apheresis is a therapy in which blood components are removed while the blood is taken outside the body, as is also the case in heart surgery. Apheresis is used in blood disorders such as blood cancer and immune-system diseases.
Patrick M. McCarthy, director of cardiothoracic surgery at Chicago's Northwestern Memorial Hospital, said his department "probably uses heparin more than anyone" and because other drugs are employed in heart surgery, it often is difficult to separate the effects of heparin from those of, say, an antibiotic.
The impact for patients from the current episode may well far outstrip that for Baxter. The company sells about $30 million of heparin injections annually, compared with $11.2 billion in corporate sales in 2007. Baxter shares were up 23 cents to $60.88 in New York Stock Exchange 4 p.m. composite trading yesterday.
Patients' reactions have ranged from stomach pain to vomiting and diarrhea, low blood pressure, speeding heartbeats and fainting. The company said low blood pressure especially "may be severe or life- threatening." The FDA's Dr. Jenkins speculated it could even theoretically involve reactions to the product's packaging.
The agency advised doctors to use small amounts of the drug infused over a longer period of time whenever possible. Dr. Jenkins said the vast majority of reactions have occurred when a large bolus of drug was infused quickly into patients, such as in less than an hour.
John J. Friedewald, a nephrologist at Northwestern, said there are alternative blood-thinning drugs, but that, "If they were to cut off 50% of the heparin supply to the country, it could become very concerning."
