UPDATE: Two Delaware Deaths Prompt Review of Baxter's Heparin
May 11 2009 - 12:01PM
Dow Jones News
Two Delaware patients died last weekend after taking heparin, a
widely-used blood thinner made by Baxter International Inc. (BAX),
prompting a review of the drug and sparking concerns about a repeat
of fatal heparin contamination in 2008.
The two deaths, which happened over the weekend, 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.
"We are not pointing fingers at Baxter," said Wallace Hudson of
Beebe Medical Center. "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, said Baxter spokeswoman Erin Gardiner. She said in an
interview that the company immediately contacted the Food and Drug
Administration. Both Baxter and the FDA quickly sent medical teams
to Delaware.
FDA spokeswoman Karen Riley said the FDA is actively
investigating the incidents. She said based on the investigation so
far these appear to be isolated incidents. The FDA and Baxter have
tested some of the heparin and haven't found any problems with it,
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 by the
hospital.
The situation isn't the same as last year's crisis in involving
tainted Chinese supplies, Gardiner said. That problem was linked to
roughly 80 deaths and led to a recall of heparin from several
companies.
Gardner said the new complications involve pre-mixed intravenous
bags of heparin. Last year's problems involved bulk supplies, vials
of the medicine and drug-coated medical devices.
Second, there are no Chinese suppliers involved, she said.
"There is one lot of heparin we are focusing on, from a North
American source," Gardiner said. "It was not produced by Chinese
manufacturers."
Third, Baxter tests on the Delaware incidents didn't detect a
contaminant found in last year's heparin illness outbreak. That
contaminant, over-sulfated chondroitin sulfate, wasn't identified
in the latest case.
Finally, the injured patients this time have suffered
inter-cranial bleeding, Gardiner said. Last year, the outbreaks
mostly involved allergic reactions and cardiac complications.
-By Alicia Mundy, The Wall Street Journal, and Jared Favole, Dow
Jones Newswires. 202-862-9243. alicia.mundy@wsj.com