Blood Substitute Trials Should Cease, Researchers Conclude

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Hemoglobin-based blood substitutes carry increased risks for death

and myocardial infarction, and no further clinical trials should be

undertaken, according to a JAMA meta-analysis and editorial.

Gathering data on five different products from published studies,

company press releases, and FDA presentations (manufacturers did not

respond to requests for additional data), researchers found

consistently increased risks for death and MI regardless of the

product or the clinical indication under which it was tested.

The researchers criticize both the manufacturers and the FDA for

their slowness in releasing data on the trials — a lag that likely

prevented full assessment of the products' dangers and may well have

contributed to trial-related death and MI, the authors write.

http://jama.ama-assn.org/cgi/content/full/299.19.jrv80007