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Opinion and Comment

Nature Biotechnology 26, 621–623 (1 June 2008) | doi:10.1038/nbt0608-621

The FDA and safety|[mdash]|beyond the heparin crisis

Cato T Laurencin & Lakshmi Nair

Interest in drug safety has grown as a result of several high-profile market withdrawals of approved drugs, particularly over the past few years. In the latest incident, the anticoagulant heparin sodium—an essential drug for use in surgery, hemodialysis and the treatment of chronic conditions, such as heart failure and deep vein thrombosis—has been found to contain traces of a contaminant associated with hundreds of adverse events.