<<"There weren't enough pigs around, you're not able to get enough heparin, and the over-sulfated chondroitin passes the test that is in place to screen heparin," >>
Baxter, FDA Probe Deaths of Two Using Blood Thinner
By ALICIA MUNDY, JARED A. FAVOLE and THOMAS M. BURTON
Two Delaware patients died last weekend after taking heparin, a widely used blood thinner made by Baxter International Inc., sparking concerns about a repeat of fatal heparin contamination in 2008.
The two deaths were confirmed by a spokesman for Beebe Medical Center in Lewes, Del. A third patient suffered medical problems as well. All three were using heparin supplied by Baxter, based in Deerfield, Ill., though there is no specific evidence tying heparin to the illnesses.
A spokeswoman for Baxter said the heparin involved in the cases of the two patients who died is from North American-derived bulk material supplied by Pfizer Inc. In the heparin deaths last year, the bulk material came from China.
Pfizer, based in New York, said it hasn't received any other reports of adverse reactions from heparin. It supplies the active ingredient for Baxter heparin, manufactured in Ohio. A spokesman for Pfizer said the company gets bulk material from both North America and China, but that "Baxter believes the lot used in Delaware used North American raw materials."
Baxter spokeswoman Erin Gardiner said that, unlike the earlier cases, the Delaware patients didn't have severe hypotension, or low blood pressure. The current symptoms involve intracranial bleeding, she said.
Baxter doesn't have any current indication of a spike in heparin-related adverse events, she said. Such a spike did occur last year, when roughly 80 deaths were linked to contaminated heparin and led to a recall of the medicine from several companies.
"We are not pointing fingers at Baxter," said Beebe Medical Center spokesman Wallace Hudson. "We don't know what's going on, but heparin is the only commonality that we were able to see ourselves."
The hospital informed Baxter on Friday that three patients had become ill, Ms. Gardiner said. She said in an interview that the company immediately contacted the Food and Drug Administration.
Baxter and the FDA sent medical teams to Delaware, and an FDA agent drove samples of the heparin bags directly to an agency laboratory in Queens, New York. "As far as we can determine at this point, this appears to be an isolated incident," FDA spokeswoman Karen Riley said.
The patients who died were a 71-year-old man and a 64-year-old woman. Both were flown by helicopter from Beebe. One died at Christiana Hospital in Delaware and the other at University of Maryland Baltimore hospital. Their names weren't released.
Ms. Gardiner said the new complications involve premixed intravenous bags of heparin. Last year's problems involved bulk supplies, vials of the medicine and drug-coated medical devices.
No Chinese suppliers are involved in the latest incidents, she said. "There is one lot of heparin we are focusing on, from a North American source," Ms. Gardiner said. "It was not produced by Chinese manufacturers."
Heparin is largely derived from the intestines of pigs and, because China is a major pork producer, it also is a major producer of the bulk chemical used in heparin.
Baxter tests on the Delaware incidents didn't detect a contaminant found in last year's heparin-illness outbreak, oversulfated chondroitin sulfate.
The FDA is testing the Baxter heparin. "Results of product testing to date by FDA and Baxter have not revealed any problems," said Ms. Riley, the FDA spokeswoman.
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