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FDA warns about bolus heparin dosing

Executive Summary

Baxter is suspending production of multi-dose vials of injectable heparin following a recent spike in adverse event reports, FDA says Feb. 11. Adverse events such as serious allergic reactions and hypotension seem to be associated with high bolus doses of the anticoagulant but not other routes of administration, the agency warns. FDA is inspecting Baxter's Cherry Hill, N.J., plant and plans to inspect the facility of the active ingredient manufacturer in China, as well as the finished dosage form manufacturing facility in New Jersey. The agency also is analyzing event reports and testing samples of Baxter's heparin product to identify the root cause of the incidents. No safety signal has been identified related to use of heparin manufactured by APP Pharmaceuticals, the other major U.S. supplier of injectable heparin. Baxter will continue to manufacture and distribute single-dose vials, and FDA is working with other manufacturers to identify alternate heparin sources in case Baxter's manufacturing suspension leads to a market shortage...

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