Baxter halts Heparin production after reports of allergic reactions

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Federal government warns health facilities of potential shortages of the blood thinner

The federal government today braced U.S. health care facilities for potential shortages of a popular blood thinner used in everything from heart surgery to kidney treatments after Baxter International Inc. stopped making certain Heparin vials on concerns about mysterious allergic reactions of some patients receiving high dosages largely in dialysis centers.

The U.S. Food and Drug Administration said potentially dangerous and "life-threatening" allergic reactions have been linked to the Deerfield-based medical product giant's multi-dose vials of Heparin blood thinner. The agency said it has begun investigating Baxter's manufacturing processes to determine the allergic reactions first reported by Missouri state health officials to the Centers for Disease Control & Prevention in mid-January.

The reactions, so far believed to be limited to "initial loading" dosages before undergoing in-center dialysis treatment or heart surgery, have included nausea, difficulty breathing and rapidly falling blood pressure that can lead to death. Four people have died after receiving Heparin but the FDA said the cases thus far were complicated and did not "follow the pattern" of the reactions of patients experiencing reactions from the so-called initial high dosages known as "bolus" doses.

Still, the FDA said the concerns are serious enough that hospitals should consider switching to another maker. Baxter makes 35 million vials annually, or half the U.S. hospital supply of Heparin, making federal officials concerned about a growing problem if the agency uncovers more adverse events with patients.

Chicago Tribuine