UPDATE: Baxter Heparin Not Tied To Deaths At Delaware Hospital
16 May 2009 - 6:13AM
Dow Jones News
Baxter International Inc. (BAX) said Friday it has finished
investigating the deaths of two patients who took the company's
heparin products and found quality issues didn't relate to their
deaths.
An array of forensic and analytical tests verify the heparin
products were pure and didn't contain any contaminants, Deerfield,
Ill.-based Baxter said in a statement.
Baxter flew a team of physicians, pharmacists and nurses to
Beebe Medical Center in Lewes, Del., within 24 hours of receiving
reports last week that three patients at the hospital suffered from
intracranial bleeding. Two of the patients died. The company said
the intracranial bleeding was a result of other complications
suffered by the patients unrelated to heparin.
"Following extensive product testing and further medical
evaluation, we are confident that the events at Beebe Medical
Center are unfortunate, isolated, institution-specific issues,
unrelated to the quality of Baxter's heparin," said Camille Farhat
of Baxter in a statement.
The company said its investigation, as well as one by U.S. Food
and Drug Administration, proves heparin is still safe and effective
to use. FDA spokeswoman Karen Riley said the agency collected
samples of the heparin, did quality tests, and determined there is
no quality problems with the drug.
When news of the patients getting sick while on heparin surfaced
last weekend, it sparked concerns about a repeat of a fatal heparin
contamination in 2008. Baxter said the heparin in this case didn't
come from China, but was purchased in bulk-form at a North American
plant through Pfizer Inc. (PFE).
These complications involved premixed intravenous bags of
heparin. Last year's problems involved bulk supplies, vials of the
medicine and drug-coated medical devices. 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.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207;
jared.favole@dowjones.com