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NIH finds some blood substitutes increased chance of death and heart attack
A recent study published in the Journal of the American Medical Association assessing the safety of five hemoglobin-based blood substitutes indicates that recipients had a 30 percent greater risk of death than patients given whole blood transfusions; they were also nearly three times more likely to suffer heart attacks.
The researchers take the U.S. Food and Drug Administration (FDA) to task for failing to adequately review the data before giving the go-ahead for human clinical trials, noting that the risks were documented as long ago as 2000 and that dozens of deaths and heart attacks suffered during the subsequent trials could have been prevented. In the wake of the findings, study co-author Charles Natanson, a senior investigator with the U.S. National Institutes of Health's Critical Care Medicine Department, called for clinical trials to be halted until more studies are done on animals to prove their safety.
Natanson and his team reviewed results of studies on blood substitutes: Hemolink (made by Hemosol BioPharma, Inc., in Mississauga, Ontario), Hemopure (made by Biopure Corp., in Cambridge, Mass.), Hemospan (made by Sangart Inc., in San Diego, Calif.), Optro (made by Baxter Worldwide in Deerfield, Ill.) and PolyHeme (made by Northfield Laboratories, Inc., in Evanston, Ill.)
Unfortunately, when hemoglobin is introduced directly into the bloodstream without the protection of red blood cells, the body will break down and remove the hemoglobin, a process that can be toxic to the kidneys, and which also narrows blood vessels, causing inflammation of surrounding tissue.
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A recent study published in the Journal of the American Medical Association assessing the safety of five hemoglobin-based blood substitutes indicates that recipients had a 30 percent greater risk of death than patients given whole blood transfusions; they were also nearly three times more likely to suffer heart attacks.
The researchers take the U.S. Food and Drug Administration (FDA) to task for failing to adequately review the data before giving the go-ahead for human clinical trials, noting that the risks were documented as long ago as 2000 and that dozens of deaths and heart attacks suffered during the subsequent trials could have been prevented. In the wake of the findings, study co-author Charles Natanson, a senior investigator with the U.S. National Institutes of Health's Critical Care Medicine Department, called for clinical trials to be halted until more studies are done on animals to prove their safety.
Natanson and his team reviewed results of studies on blood substitutes: Hemolink (made by Hemosol BioPharma, Inc., in Mississauga, Ontario), Hemopure (made by Biopure Corp., in Cambridge, Mass.), Hemospan (made by Sangart Inc., in San Diego, Calif.), Optro (made by Baxter Worldwide in Deerfield, Ill.) and PolyHeme (made by Northfield Laboratories, Inc., in Evanston, Ill.)
Unfortunately, when hemoglobin is introduced directly into the bloodstream without the protection of red blood cells, the body will break down and remove the hemoglobin, a process that can be toxic to the kidneys, and which also narrows blood vessels, causing inflammation of surrounding tissue.
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