Bristol Myers reports liver safety events, including a patient death, in trial

Bristol Myers Squibb reported a limited number of liver-related safety events in testing of admilparant, including a patient death. BioPharma Dive said it was unclear whether the drug was to blame. Endpoints News described the case as fatal liver injury.

In a May amendment for European Union trial sites, the company classified liver injury as an important potential risk and required closer monitoring of participants with abnormally high liver enzyme levels. According to the amendment, most events were mild, transient or consistent with hepatic adaptation. BioPharma Dive reported that the fatality resulted from multi-organ failure involving liver damage, immune damage to red blood cells and widespread clotting. The enrollee had underlying lung disorders and other complications.