Scientific Publications by FDA Staff

J Environ Sci Health C 2015 Oct 2;33(4):404-21

Blood pyrrole-protein adducts--a biomarker of pyrrolizidine alkaloid-induced liver injury in humans.

Ruan J, Gao H, Li N, Xue J, Chen J, Ke C, Ye Y, Fu PP, Zheng J, Wang J, Lin G

Pyrrolizidine alkaloids (PAs) induce liver injury (PA-ILI) and are very likely to contribute significantly to drug-induced liver injury (DILI). In this study we used a newly developed UHPLC-MS-based method to detect and quantitate blood pyrrole-protein adducts in DILI patients. Among the 46 suspected DILI patients, 15 were identified as PA-ILI by the identification of PA-containing herbs exposed. Blood pyrrole-protein adducts were detected in all PA-ILI patients (100%). These results confirm that PA-ILI is one of the major causes of DILI and that blood pyrrole-protein adducts quantitated by the newly developed UPLC-MS method can serve as a specific biomarker of PA-ILI.