Patients Remain At Risk - Despite the Baxter Heparin Recall

Boston MADialysis patients should beware--they are more exposed to heparin than any other single group of patients in the US, and remain at serious risk for allergic reactions to tainted product, despite the national recall of Baxter heparin.

According to Doctor Ajay Singh, the Clinical Director and Renal Division Director of Dialysis Services at Brigham and Women's Hospital in Boston Mass., some 450,000 patients are on dialysis in the United States, and the vast majority use heparin, he said in a recent interview.

Why? Heparin, a blood thinner made from the pig intestines, is used during dialysis to help prevent blood clots from forming. But to be clear, people with kidney disease are not the only group of patients at risk. People undergoing surgery, including heart surgery, and patients with deep vein thrombosis receive heparin: it is used in patients who are at risk of developing deadly blood clots in the lungs and blood stream.

However, on February 11, 2008, the Federal Food and Drug Administration (FDA) announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of injectable heparin due to reports of serious allergic reactions and hypotension among dialysis patients. According to the Centers for Disease Control's Mortality and Morbidity Weekly Report (MMWR), it was reports of allergic reactions to heparin in several patients undergoing dialysis at a pediatric hospital in the Missouri in November 2007 that triggered the alarm. After some investigation, a common thread appeared--most of the patients had been given intravenous heparin during dialysis. All the heparin had originated from Baxter Healthcare Corp, who subsequently issued a voluntary recall in January 2008, of nine lots heparin which appeared to contain a contaminant.

According to the health care provider who reported the allergic reactions to the Missouri Department of Health and Senior Services, the symptoms people experienced included facial swelling, tachycardia, low blood pressure, urticaria, and nausea, which occurred just minutes after starting dialysis.

Since then, hundreds of reports of serious allergic reactions have emerged, and possibly as many as 19 deaths related to the Baxter-produced heparin. As of January 30, 2008, there were 65 cases of allergic reactions confirmed or thought to probably result from the tainted heparin, among just 53 dialysis patients. These incidents occurred at 19 dialysis facilities in 12 states. And many more cases are currently under investigation.

The source of the contamination in the heparin has been traced to seemingly unregulated, small sweatshop-type production facilities in China. This latest product-tampering scandal follows on the heels of several others, all highly consequential, such as the lead-contaminated paint on children's toys; toothpaste containing diethylene glycol, an ingredient of anti-freeze which can cause liver and kidney disease; pet food containing highly toxic melamine used in the manufacturing of plastic, which killed thousands of pets; and cold medicine containing a counterfeit ingredient, which poisoned 174 people and likely contributed to the deaths of 115 people in Panama. In all these cases it appears that the addition of the fraudulent ingredients was not accidental.

The CDC/FDA investigation into the contaminated heparin is ongoing and could likely continue for some time, as the recall is no guarantee that people are safe. An additional allergic reaction was reported on January 21, 2008, after a dialysis patient was administered Baxter heparin from one of the recalled lots. The CDC subsequently reported that they have "found indications of delays in removing the recalled lots of heparin from distribution, which might result in continued exposures. In addition, these reactions might not be limited to hemodialysis settings. One cardiac-care facility has reported seven allergic-type reactions among cardiac patients who received heparin from lots that were later recalled. CDC and state health departments are investigating these reactions."

To-date, the contaminant in the heparin has not been identified. Dr. Singh believes that over the long-term countries that import drugs like heparin need to develop oversight procedures that test the active pharmaceutical agents along their supply line and also of the finished product. "The drug label should also include "country of origin" so consumers and doctors know where these drugs originate," he said.

Needless to say, the Baxter heparin recall has left the medical community scrambling, as Baxter is one of the largest suppliers of heparin in the United States. When asked how the dialysis unit at Brigham and Women's Hospital was coping with this crisis, Dr. Singh said, "We have used alternative providers, and we have increased our vigilance for possible heparin reactions."