Recombinant human activated protein C in sepsis: inconsistent trial results, an unclear mechanism of action, and safety concerns resulted in labeling restrictions and the need for phase IV trials.

Animals Anti-Infective Agents/adverse effects,pharmacokinetics,therapeutic use Clinical Trials, Phase II as Topic Clinical Trials, Phase III as Topic Clinical Trials, Phase IV as Topic Disease Models, Animal Drug Approval Drug Labeling Humans Protein C/adverse effects,pharmacokinetics,therapeutic use Rats Recombinant Proteins/adverse effects,pharmacokinetics,therapeutic use Sepsis/drug therapy

Anti-Infective Agents Protein C Recombinant Proteins drotrecogin alfa activated