FDA Probes 4 Heparin Deaths
Baxter Healthcare Halts Multiple-Dose Vials of Heparin; Not Clear if Drug Caused Deaths
Feb. 11, 2008 -- The FDA today announced that Baxter Healthcare has
temporarily stopped making multiple-dose vials of the injectable blood-thinning
drug heparin because of recent reports of four deaths and other serious
Those reports involve "bolus" doses -- high doses given by health
care providers over a short time. The cases don't involve lower doses or slower
The temporary suspension applies only to Baxter's multiple-dose vials of
heparin. It doesn't apply to other heparin makers or Baxter's single-dose vials
Today's FDA announcement is for doctors and other health care providers
because they're responsible for administering heparin bolus doses.
Serious reactions to Baxter's heparin bolus doses have included difficulty
breathing, nausea, vomiting, excessive
sweating, and rapidly falling blood pressure that can lead
to life-threatening shock.
It's not clear if the drug caused any of the four deaths, notes John
Jenkins, MD, director of the FDA's Office of New Drugs.
Since late December, the FDA and Baxter have received "approximately 350
adverse event reports, and approximately 40% of those reports have been
characterized as serious," Jenkins said at a news conference.
Most of the cases took place at kidney dialysis centers. Other cases have
included patients undergoing heart surgery or a specialized blood cell
treatment called photopheresis.
The FDA is investigating Baxter's heparin production and hasn't yet
identified the source of the problem.
Baxter will continue making single-dose vials of heparin. But Jenkins warns
that those vials should not be used to make bolus doses.
"Health care providers should be aware that serious adverse events of
the same type have been reported in a few cases where single-dose vials of
Baxter heparin were combined in order to give a large bolus dose to a
patient," Jenkins says. "It appears that the adverse reactions that we
are seeing are related to bolus dosing, and therefore even using single-dose
vials to generate the dose necessary to get the bolus could be of
More than a million multiple-dose vials of heparin are sold monthly in the
U.S., and Baxter makes half of them. To avoid an immediate, severe shortage of
heparin, Baxter isn't recalling multiple-dose vials of heparin that are already
on the market.
The FDA offers this advice about Baxter's heparin to health care
- Give the drug as an intravenous infusion, not as a bolus dose, whenever
- Use the lowest dose necessary at the slowest infusion rate acceptable.
- Carefully monitor patients for adverse events and have staff and equipment
available to intervene, if necessary.
- Doctors should weigh the risks and benefits of pretreatment with
corticosteroids or antihistamines to relieve
symptoms of allergic reactions.