Baxter Stops Production of Heparin
Posted by Administrator (admin) on Feb 12 2008 at 4:34 PM
Heparin >>

The Food and Drug Administration (FDA) asked doctors Monday to stop using the blood thinner heparin produced by Baxter HealthCare Corp, after receiving innumerous reports of allergic reactions four patient deaths.

FDA said that they had received 350 reports of side effects in 2008. The side effects include vomiting, breathing troubles and nausea. In addition to this, four people died after taking the drug. However, it’s not yet sure if the drug was to be blamed for this.

Baxter, which makes fifty percentage of heparin sold in the United States, has announced that they were suspending the production of multi-dose vials of injectable form of the drug for the time being. Heparin, which is derived from pig intestines, is widely used to prevent blood clots in patients undergoing heart surgery and kidney dialysis. The drug has been marketed in the United States since 1930.

Baxter had voluntarily recalled nine vials lots after heard that dialysis patients suffered allergic reactions such as dizziness, fainting and racing heart beat when the drug was used.

The cause of the allergic reactions and death is not known so far. FDA says that government investigators are checking Baxter’s production sites for locating the source of the issue. Baxter said that they would cooperate with the inspection.

FDA office director John Jenkins said a shortage problem is expected in the near future due to the suspension of the product. FDA has asked Illinois based APP Pharmaceuticals, the second major producer of heparin, and other pharmaceutical companies to increase production of heparin.

Any allergic-type reaction to heparin infusion can be reported to FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

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