NEW YORK, NY -- February 11, 2008 -- Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of injectable heparin sodium due to an unusual increase in serious reactions, including 4 deaths. Since mid-December 2007, approximately 350 serious reactions associated with the product have been reported. This compares to less than 100 reports in all of 2007. The US Food and Drug Administration is encouraging healthcare professionals to use an alternate blood thinner when possible.
All recent serious reactions have occurred in patients receiving high bolus doses of the drug. These reactions 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.
Affected patients include those on hemodialysis; patients undergoing certain types of cardiovascular surgery; patients undergoing photopheresis and plasmapheresis, and some patients who have blood clots in arteries or veins.
At this time, the FDA has not issued a recall of all multi-dose vials of heparin sodium manufactured by Baxter. An abrupt withdrawal could cause a shortage of a medically necessary drug because Baxter manufacturers approximately 50 percent all heparin sodium used in the United States.
The FDA explains that the increase in occurrence of adverse events with Baxter's heparin appears to be related to the bolus dosing using multi-dose vials. However, several other cases include patients who received a bolus dose after their healthcare professional combined heparin from single-dose vials.
An increase in serious reactions has not been seen with use of small amounts and/or slow infusions of heparin sodium.
Physicians, dialysis center staff, and healthcare providers are advised to use an alternate source of heparin or another blood-thinning drug when possible. When only Baxter product is available:
-- Administer the heparin as an infusion (not a bolus) whenever possible.
-- Use the lowest dose necessary at the slowest infusion rate acceptable to obtain the desired clinical effect.
-- Closely monitor the patient for adverse events, particularly hypotension and signs and symptoms of hypersensitivity and ensure that resuscitation equipment is available.
-- Consider pretreatment with corticosteroids or antihistamines, although it is not known if such pretreatment is effective.
"FDA concurs with Baxter's decision to halt manufacture of heparin sodium in multiple-dose vials," said Janet Woodcock, MD, 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 remain."
Baxter's move to halt manufacturing comes just a few weeks after the company voluntarily recalled 9 lots of heparin sodium in response to the increase in severe reactions. Since then, FDA has learned of adverse events that extend beyond the recalled lots.
The FDA is working with heparin sodium manufacturers to identify and ensure adequate supplies of heparin sodium for future clinical use.
SOURCE: US Food and Drug Administration
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