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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on March 05, 2008, 10:01:52 AM
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Posted on Tue, Mar. 04, 2008
Anxiety is rising over recall of blood-thinning drug heparin
By ALAN BAVLEY
The Kansas City Star
The life-threatening allergic reactions started just minutes after the kids were hooked up to dialysis machines at St. Louis Children’s Hospital.
The young patients’ tongues and eyelids swelled. Their hearts raced. Their blood pressure dropped.
Doctors at the hospital reported the problems early last month to state health officials and the federal Centers for Disease Control and Prevention.
The alarm they sounded rapidly escalated into the nationwide recall of heparin made by Baxter Healthcare Corp. and an international investigation into how the ubiquitous drug is manufactured.
“We were very concerned about the cause of these allergic reactions,” said Alexis Elward, the physician in charge of the investigation at Children’s Hospital. “We looked at the equipment, the chemicals, the medical literature. Heparin was definitely on the list.”
Kansas City hospitals that were contacted by The Star said they have had no problems with heparin.
Heparin is a blood thinner that frequently is used to prevent blood clots from forming after surgery or during kidney dialysis. It also is used to treat clots in the lungs and legs.
As of last week, the Food and Drug Administration had received reports of 21 deaths and 448 adverse reactions associated with heparin. Not all the incidents, however, have been linked directly to Baxter’s products, nor have officials determined how many of these reactions heparin actually caused.
Baxter produces about 50 million doses of heparin a year, roughly half the nation’s supply. The company has issued voluntary recalls for all but a small number of its heparin products, and it has stopped heparin production at its Cherry Hill, N.J., plant.
Other manufacturers have stepped in to maintain supplies.
FDA inspectors have visited a factory in China that provided Baxter with the active ingredient for heparin, which is made from the linings of pig intestines. Inspectors found potential quality-control issues but did not reach any conclusions.
The reason for the allergic reactions remains a mystery.
“We’re continuing our investigation to determine the root cause,” said Baxter spokeswoman Deborah Spak. “They have been running these tests, literally hundreds of tests, around the clock.”
And the investigation continues at Children’s Hospital.
“We continue to look at all possible causes,” Elward said. “We don’t know for sure that it is just the heparin.”
Elward said the first allergic reactions at the hospital occurred in two dialysis patients a couple of days apart in November. They did not set off alarms because such reactions happen in dialysis units from time to time.
“For us to have one or two cases in November wouldn’t be above our baseline rate,” Elward said.
At first, doctors assumed the cause was a chemical used to sterilize dialysis equipment that often is responsible for allergic reactions. They switched to a different cleanser.
Then on Jan. 4, two children had allergic reactions within minutes of being hooked up to the dialysis machines. Elward was brought in to investigate. She immediately contacted the FDA, the CDC and the state and local health departments.
All told, four children at the St. Louis hospital were affected in November or January. Each had two allergic reactions. All recovered.
The CDC alerted health departments and electronic mailing lists that reach dialysis centers. Within a few days the agency was contacted by a dialysis supply company that had recent reports of about 50 similar reactions among adult patients in six states. A second company told the CDC that it had reports dating to early December.
On Jan. 9, the CDC notified the FDA, and the two agencies began collaborating on an investigation.
Meanwhile, Baxter was receiving unusually large numbers of reports of allergic reactions associated with its heparin.
“These sorts of reactions are known to occur with heparin, but we were seeing a significantly higher-than-expected rate over the past few months,” said Baxter spokeswoman Spak.
Baxter notified the FDA in January. On Jan. 16, the agency inspected Baxter’s New Jersey plant. The next day, Baxter voluntarily recalled nine lots of heparin. It broadened the recall last week.
Spak said Baxter received all the active ingredients for its heparin products from China.
“It’s been that way for years. There is not enough produced in the United States to meet the need,” she said. “The majority of the world’s pig population is in China.”
To reach Alan Bavley, call 816-234-4858 or send e-mail to abavley@kcstar.com.
http://www.kansascity.com/105/story/517404.html
PHOTO: The investigation into heparin has stretched to Xinwangzhuang, China, where the active ingredient for the blood-thinning drug is produced from the linings of pig intestines.
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this is some scary shit!