Heparin recall could affect dialysis patients

Dialysis patients shouldn’t panic over the recent voluntary recall of a drug used as part of their kidney-failure treatments, but there is concern about a possible shortage, a Boston kidney specialist said.

On Monday the US Food and Drug Administration announced that Baxter Healthcare Corp. had stopped making multi-dose vials of the blood-thinning drug heparin after reports of 350 serious allergic reactions, including four deaths, in patients who received the drug. It still makes single-dose vials.The exact cause has not been pinpointed, but most of the problems occurred in patients who were given large doses.

A plant in China that has not been inspected by the FDA makes the active ingredient in heparin for Baxter, according to a story in today’s New York Times. That plant and one in New Jersey where the drug is packaged will be inspected by the agency.

Heparin, which is derived from pig intestines, has been used since the 1930s to avoid potentially deadly clots in blood vessels or the lungs. Patients having surgery, particularly cardiovascular procedures, frequently get the drug, but it is most commonly given to patients who need regular dialysis treatments to filter waste from their blood when their kidneys can no longer function.

“The people on dialysis are the most likely to be profoundly affected by this, and since there are 450,000 patients on dialysis in the United States, and the vast majority use heparin, it could be quite an issue,” Dr. Ajay Singh, who oversees the dialysis program at Brigham and Women's Hospital, said in an interview yesterday. About 150 patients receive dialysis as outpatients at the hospital, where about 3,500 treatments are given per year. He and others in the renal division are discussing alternative treatments.

“The first thing is, these reactions are rare, in the context of many millions of applications of this drug,” Singh said. “I don’t think patients should panic.”

Switching to heparin made by other manufacturers would be the first choice. A minority of patients can have their dialysis modified to avoid needing heparin, Singh said. And there are other anticoagulant drugs to turn to, such as a drug called hirudin that is derived from leeches.

If dialysis centers have only Baxter heparin, the FDA recommends administering only low doses at the slowest possible infusion rate while closely monitoring patients.