To explore persistent safety concerns surrounding hemoglobin-based blood substitutes (HBBSs), researchers analyzed 16 controlled trials involving 3,711 surgical, trauma, and stroke patients who received five different HBBSs. This group was compared with patients with similar conditions who received standard care with 0.9% sodium chloride solution, packed red blood cells, and plasma expanders.

Significantly fewer patients receiving standard care died: 123 compared with 164 in the HBBS group. Only 16 patients receiving standard care experienced myocardial infarction (MI), compared with 59 in those in the test group.

Study authors say that 11 clinical trials completed in 2000 showed the elevated risks, but that such data weren't made available to the public. They advocate for laws requiring full disclosure of drug safety and effectiveness data to the scientific and medical communities.

Source: Natanson C, et al., Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death, JAMA, published online April 28, 2008.