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The U.S. Food and Drug Administration
announced today that Baxter Healthcare Corporation has
temporarily stopped manufacturing multiple-dose vials of the
injectable blood-thinning drug heparin due to reports of serious
allergic reactions and hypotension (low blood pressure) in
patients who receive high "bolus" doses of the drug.
Serious reactions to the drug have included
difficulty breathing, nausea, vomiting, excessive sweating, and
rapidly falling blood pressure that can lead to life-threatening
shock. Four people have died after receiving heparin, although
the relationship to the drug is unclear.
Heparin sodium is derived from pig intestines
and has been marketed in the United States since the 1930s.
Millions of patients benefit from the intravenous administration
of this drug every year to avoid potentially life-threatening
blood clots in the veins, arteries, and lungs.
"FDA concurs with Baxter's decision to halt
manufacture of heparin sodium in multiple-dose vials," said
Janet Woodcock, M.D., FDA's deputy commissioner for scientific
and medical programs, chief medical officer, and acting director
of its Center for Drug Evaluation and Research. "FDA is
vigorously investigating to determine the root cause of these
serious reactions associated with the use of heparin made by
Baxter. In the meantime, patients and health care professionals
who cannot obtain alternative sources of heparin should use
caution in administering any Baxter multiple-dose vials that
Heparin is commonly used before certain types
of surgery, including coronary artery bypass graft surgery, and
in kidney patients before they undergo dialysis. In some
situations, heparin treatment is initiated using a high bolus
dose given directly into the bloodstream (intravenously) over a
short period of time, usually less than one hour. The reported
adverse events occurred in patients who were given heparin in
this form of administration. There are many other uses of
heparin involving lower doses or administration over a longer
period of time; adverse events have not been seen with those
About 350 adverse events associated with the
Baxter product have been reported since the end of last year
compared to less than 100 reports in 2007. Most of the events
have taken place at hemodialysis centers, almost exclusively
involving patients receiving a bolus dose – which is a high dose
administered over a short time. While most of the reports
involve multiple-dose vials, several cases include patients who
received a bolus dose after their health care professional
combined heparin from single-dose vials.
The Missouri Department of Health and Senior
Services first notified the Centers for Disease Control and
Prevention (CDC) in January of several severe allergic-type
reactions to heparin that occurred at a single pediatric
hospital beginning in November. The CDC in turn alerted FDA and
Baxter, prompting the company's voluntary recall of nine lots of
heparin on Jan. 17.
Since then, FDA has learned of adverse events
that extend beyond the recalled lots and involve patients
receiving heparin for other purposes besides hemodialysis.
Recent cases have included patients undergoing cardiac surgery
and a specialized blood cell treatment known as photopheresis.
Over one million multiple-dose vials of
heparin are sold per month in the United States; half of the
vials are manufactured by Baxter of Deerfield, Ill. FDA is
currently investigating whether similar events have been seen
with other heparin manufacturers.
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