Resources for Food and Drug Administration (FDA)

Blood Substitutes Spur Death; FDA Inaction Criticized

www.bloomberg.com

Artificial blood raised death risks by 30 percent and almost tripled the odds of heart attacks in 16 clinical trials analyzed by researchers who say U.S. regulators should have stopped the studies eight years ago.

Five trials involving substitute blood products are ongoing, and a new one is about to begin, the researchers reported. The Food and Drug Administration is holding a workshop in Bethesda, Maryland, tomorrow to discuss safety of the products.

The researchers, in a report in the Journal of the American Medical Association, said the FDA in 2000 received data on individual studies showing increased risks that should have triggered suspension of testing until a large-scale analysis. Now the agency should end all trials and Congress should review rules forcing the FDA to keep information on new products confidential for competitive reasons, the researchers said.

View the Resource

Share or bookmarklet this web page at: