ATLANTA (AP) -- More than 50 dialysis patients in 12 states have come down with
allergic reactions that are being blamed on recalled batches of a blood thinner,
federal health officials said Friday.
The cases are being called the largest national outbreak of treatment-related
allergic reactions ever seen in dialysis patients.
Since the middle of November, 53 dialysis patients developed reactions after
receiving injections of heparin made by Baxter Healthcare Corp. And another 36
reports are under investigation, according to the U.S. Centers for Disease
Control and Prevention.
None of the patients died, CDC officials said.
Baxter last month announced the voluntary recall of nine lots of multi-dose
vials after learning of adverse events in dialysis patients, but the details of
the outbreak were not disclosed until the CDC released the information late
Friday afternoon.
The heparin has been tested for bacteria and endotoxin, but neither was found,
said Dr. Alex Kallen, part of the CDC team looking into the illnesses.
"We don't know what the problem is," but heparin remains the leading candidate
as the cause, said Dr. Priti Patel, another CDC investigator.
Kidney patients receive heparin to prevent clotting of blood during the dialysis
process. Allergic-type reactions occurred within minutes of starting dialysis,
CDC officials said.
The symptoms included facial swelling, nausea, rapid heart beat and decreased
blood pressure. Some of these reactions may be severe or life threatening,
Baxter officials said when announcing last week's recall.
Most of the patients improved after their dialysis session was interrupted or
they were treated with antihistamines or steroids, CDC officials said.
The cases were reported at 19 dialysis facilities in California, Florida,
Minnesota, Missouri, New Jersey, New York, North Carolina, North Dakota, Ohio,
Pennsylvania, West Virginia and Wisconsin.
The recalled lots all came from a Baxter facility in Cherry Hill, N.J. The
recall was specific to thousands of 1,000-unit, multi-dose vials, a company
spokeswoman said.
CDC officials are also looking into allergic-type reactions in seven cardiac
patients in North Carolina who got Baxter-made heparin. They're also looking
into four cardiac cases in Florida, including one patient who died.
"We're investigating. There is one patient death that may be associated" with
the 1,000-unit vials, said Erin Gardiner, a Baxter spokeswoman.
The investigation is not related to reports of about 40 people in Illinois and
Texas who developed blood infections after taking heparin made by another
company, Sierra Pre-Filled. Those infections were caused by a bacteria called
Serratia marcescens found in a single batch of heparin-filled syringes made by
that company in Angier, N.C.
Source : The Associated Press
