Agency Continues to Issue Alerts, Probe Heparin Issue

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The FDA has continued to issue safety alerts and investigate events surrounding the injectable blood thinner heparin (FDA News, April 2008) and its “clear link” to 81 deaths in U.S. patients who received doses of the drug.

 

The agency sent a follow-up letter to heparin device manufacturers and initial distributors requesting information on sources of the drug, verification of contamination tests, and plans to ensure that future lots of heparin will be contaminant-free.

 

IV heparin is commonly administered before surgery and before kidney patients undergo dialysis, to prevent potentially life-threatening blood clots.

 

A list of recalled heparin products is available at http://www.fda.gov/cder/drug/infopage/heparin/#recalls.

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