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FDA breached integrity over investigation of contaminated heparin

BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c6529 (Published 16 November 2010) Cite this as: BMJ 2010;341:c6529
  1. Janice Hopkins Tanne
  1. 1New York

The US Food and Drug Administration has been criticised for the way it investigated how a batch of contaminated heparin came into medical use in 2008.

The contaminated heparin, produced by Baxter Healthcare Corporation, was recalled in 2008 after 81 patients died and 350 adverse events were reported (BMJ 2008;336:412, doi:10.1136/bmj.39496.419248.DB).

Baxter provides about half the supply of heparin in the United States. But the blood product’s main ingredient was imported from a Chinese source that was never traced, as some Chinese producers refused to cooperate with the FDA.

A report from the independent Government Accountability Office criticises …

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