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Baxter suspends heparin production

Baxter International has temporarily suspended production of is blood-thinning drug heparin in multi-dose vials after reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

Baxter International has temporarily suspended production of is blood-thinning drug heparin in multi-dose vials after reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.

According to the US Food and Drug Administration (FDA) 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 FDA is quick to point out links between the deaths and heparin are unclear.

Baxter originally recalled nine lots of heparin sodium injection 1,000 units/mL 10 and 30mL multi-dose vial as a precautionary measure, but since then has received reports of similar adverse reactions occurring in other lots of 1,000 units/mL, 10 and 30mL multi-dose vials; 5,000 units/mL and 10,000 units/mL multi-dose vials; and 5,000 units/mL single-dose vials when single doses were combined to create a larger bolus dose.

"FDA concurs with Baxter's decision to halt manufacture of heparin sodium in multiple-dose vials," said Janet Woodcock, 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," Woodcock concluded.

Heparin is usually used before certain surgical procedures, 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 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, and the FDA reports that adverse events have not been seen in those situations.

12th February 2008

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