Abstract
Background: A large number of idiosyncratic drug induced liver injury (iDILI) and herb induced liver injury(HILI) cases of variable quality has been published but some are a matter of concern if the cases were not evaluated for causality using a robust causality assessment method (CAM) such as RUCAM (Roussel Uclaf Causality Assessment Method) as diagnostiinjuryc algorithm. The purpose of this analysis was to evaluate the worldwide use of RUCAM in iDILI and HILI cases. Methods: The PubMed database (1993–30 June 2020) was searched for articles by using the following key terms: Roussel Uclaf Causality Assessment Method; RUCAM; Idiosyncratic drug induced liver injury; iDILI; Herb induced liver injury; HILI. Results: Considering reports published worldwide since 1993, our analysis showed the use of RUCAM for causality assessment in 95,885 cases of liver injury including 81,856 cases of idiosyncratic DILI and 14,029 cases of HILI. Among the top countries providing RUCAM based DILI cases were, in decreasing order, China, the US, Germany, Korea, and Italy, with China, Korea, Germany, India, and the US as the top countries for HILI. Conclusions: Since 1993 RUCAM is certainly the most widely used method to assess causality in IDILI and HILI. This should encourage practitioner, experts, and regulatory agencies to use it in order to reinforce their diagnosis and to take sound decisions.
Highlights
Idiosyncratic drug induced liver injury (DILI), in short termed idiosyncratic drug induced liver injury (iDILI), and herb induced liver injury (HILI) are complex diseases and received much attention in recent years [1,2,3,4,5,6,7,8,9]
A liver injury caused by exogenous compounds such as drugs and herbs is defined by specific threshold values established for the liver tests (LTs) alanine aminotransferase (ALT) and alkaline phosphatase (ALP), with current serum activities considered as relevant for Alanine aminotransferase (ALT) ≥ 5 × ULN and ALP ≥ 2 × ULN [15] provided that ALP is of hepatic origin
Phase 2 started in 2005 with overall 7695 annually published Roussel Uclaf Causality Assessment Method (RUCAM) based Drug induced liver injury (DILI) cases (Figure 1) [115,126,147,148]. Among these were 461 cases provided by Andrade et al from Spain retrieved from a prospective study involving various drugs [115], additional 784 cases from Sweden were published by Björnsson and Olsson retrieved from a prospective study of DILI by various drugs [126], whereas from the US 2 case reports of DILI by amoxicillin and clavulanate were presented by Fontana et al [147] as well as a large cohort of DILI caused by ximelagatran occurred in clinical trials was published by Lee et al [148]
Summary
The PubMed database (1993–30 June 2020) was searched for articles by using the following key terms: Roussel Uclaf Causality Assessment Method; RUCAM; Idiosyncratic drug induced liver injury; iDILI; Herb induced liver injury; HILI. Results: Considering reports published worldwide since 1993, our analysis showed the use of RUCAM for causality assessment in 95,885 cases of liver injury including 81,856 cases of idiosyncratic DILI and 14,029 cases of HILI. Among the top countries providing RUCAM based DILI cases were, in decreasing order, China, the US, Germany, Korea, and. With China, Korea, Germany, India, and the US as the top countries for HILI. Conclusions: Since 1993 RUCAM is certainly the most widely used method to assess causality in IDILI and HILI. This should encourage practitioner, experts, and regulatory agencies to use it in order to reinforce their diagnosis and to take sound decisions
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