2008-05-01

On February 11, 2008, the U.S. Food and Drug Administration (FDA) advised health-care practitioners to limit use of Baxter's injectable blood-thinning drug heparin due to serious allergic reactions and hypotension in patients who receive high "bolus" doses of the drug. Since then, Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable heparin. They have also recalled all of their multi-dose and single-use vials of heparin. And, as a precautionary measure, they have recalled heparin lock flush solutions.

Then on March 21, a second supplier, B. Braun Medical Inc., began recalling lots of heparin as a precautionary measure. To date, the company has not received any adverse event reports related to this issue.

Supplies of heparin have been recalled in France, Italy, and Denmark because they are contaminated or are suspected of being contaminated. Batches of the drug have recently been recalled in Germany and Japan, as well.

After launching an investigation in both the United States and abroad, the FDA found a heparin-like compound present in some of the active pharmaceutical ingredients produced by Scientific Protein Laboratories (Baxter and Braun's supplier). The contaminant has been indentified as a modified form of a cheap and widely used dietary supplement sold to relieve joint pain. FDA officials are currently investigating whether the compound, chemically modified chondroitin sulfate, was intentionally added or was added by accident. In either case, it is not part of the prescribed manufacturing process. Heparin is made from the intestines of pigs, and chondroitin sulfate can be produced from pig cartilage.

For more information, including questions and answers on heparin sodium injection, go to the FDA's Web site.

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