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FDA warns docs to stop using Baxter's heparin

/ Source: news services

Government regulators told doctors Monday to switch from using a blood thinner made by Baxter International, following hundreds of reports of allergic reactions.

The Food and Drug Administration said it has received 350 reports in 2008 of side effects, including vomiting, nausea and difficulty breathing. Four people died while taking the drug, though the agency said it wasn't clear if the drug was to blame. In all of 2007, the agency received 100 reports of problems with the drug.

Before FDA's announcement, Baxter said on Monday it would stop manufacturing multiple-dose vials of its injectable heparin. Last month, the Deerfield, Ill.-based company voluntarily recalled nine lots of the vials after finding out dialysis patients had allergic reactions to it. Their problems ranged from dizziness and fainting to racing heart beat.

The company said Monday the problems were not limited to the nine lots in the recall. Government inspectors are examining Baxter's manufacturing sites to locate the source of the problems, FDA said.

Baxter said Monday it would cooperate with the investigation.

Agency officials considered a recall, but said they decided not to because it would create a dangerous shortage of the drug. Baxter accounts for about half the U.S. supply.

Instead, the FDA warned doctors to use it with "caution when medically necessary."

"There's going to be a shortage problem in immediate and long term future due to the suspension of manufacturing by Baxter," said John Jenkins, an FDA office director.

Kidney-failure patients receive heparin to prevent clotting of blood during the dialysis process. The drug is also used in certain types of heart surgery.

FDA said nearly all the reported problems have been in dialysis patients who received high doses of heparin over a short time. Agency scientists said doctors who continue to use the drug should use the lowest doses possible and administer it slowly.

Baxter sold about 35 million vials of injectable heparin in the U.S. last year, with revenue of $30 million. The other major producer of heparin in the U.S. is Illinois-based APP Pharmaceuticals.

FDA officials asked APP and other pharmaceutical companies to increase production of heparin to offset the lost Baxter product.

The medicine is also at the center of a lawsuit filed by actor Dennis Quaid over an overdose given to his newborn twins. However, the Quaid case involved single dose vials that are not involved in the recall or current side effect mystery.

The Quaid suit accuses Baxter of failing to put clear distinguishing labels on certain vials of heparin, and failing to recall the product after three infants died because of a mix-up.