Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

Abstract

Causality assessment of suspected drug induced liver injury (�ILI) and herb induced liver injury (HILI) is hampered by the lack of a standardized approach to be used by attending physicians and at various subsequent evaluating levels. The aim of this review was to analyze the suitability of the liver specific Council for International Organizations of �edical Sciences (CIO�S) scale as a standard tool for causality assessment in �ILI and HILI cases. �ub�ed database was searched for the following terms: drug induced liver injury; herb induced liver injury; �ILI causality assessment; and HILI causality assessment. The strength of the CIO�S lies in its potential as a standardized scale for �ILI and HILI causality assessment. Other advantages include its liver specificity and its validation for hepatotoxicity with excellent sensitivity, specificity and predictive validity, based on cases with a positive reexposure test. This scale allows prospective collection of all relevant data required for a valid causality assessment. It does not require expert knowledge in hepatotoxicity and its results may subsequently be refined. Weaknesses of the CIO�S scale include the limited exclusion of alternative causes and qualitatively graded risk factors. In conclusion, CIO�S appears to be suitable as a standard scale for attending physicians, regulatory agencies, expert panels and other scientists to provide a standardized, reproducible causality assessment in suspected �ILI and HILI cases, applicable primarily at all assessing levels involved.© 2014 Baishideng �ublishing Group Co., Limited. All rights reserved.Key words: �rug induced liver injury; �rug hepatotoxicity; Herb induced liver injury; Herbal hepatotoxicity; Causality assessment Core tip: We propose that the attending physicians caring for patients with assumed drug induced liver injury and herb induced liver injury should use the Council for International Organizations of �edical Sciences (CIO�S) scale for causality assessment. This approach includes the option of subsequent refinement of the CIO�S based results by expert panels and regulatory agencies. The use of the CIO�S scale as an identical

Rivaroxaban postmarketing risk of liver injury

“…Furthermore, even the widely accepted RUCAM causality scale for DILI has limitations, and discrepancies between expert evaluations vs. standardized scales have been widely discussed and studied [6,20,21]. At least all cases reported to our center were evaluated using senior expertise and the most recognized standardized DILI-specific criteria.…”

“…According to standardized RUCAM criteria for the assessment of drug-induced liver injuries [4][5][6] we assigned a causality of "highly probable" (total score: 9) to rivaroxaban. Key criteria for this assessment were a close and plausible temporal relationship, a known and labeled adverse drug reaction, compatible histological findings, and negative differential diagnosis for alternative causes.…”

“…Time in relation to start of rivaroxaban. 6 Roussel Uclaf Causality Assessment Method, endorsed by the Council of International Organizations of Medical Sciences (see also references 1 and 2). 7 Hy's case criteria: ALT >3x ULN and TB >2x ULN without initial AP increase / cholestatic enzyme pattern (see also reference 6).…”

Lesser celandine (pilewort) induced acute toxic liver injury: The first case report worldwide

“…In the decision of different injury types, ratio R (ALT/ALP activity at the time liver injury is suspected, activity is measured by multiples of the highest point of the normal values) is used. If ALT > 2N or R ≥ 5, hepatocellular injury is assumed; if ALP > 2N or R ≤ 2, injury is cholestatic; if ALT > 2N and ALP is increased, with R > 2 and R < 5, mixed injury is assumed [11] . There are no diagnostic tests or specific criteria for herb induced hepatotoxicity.…”

“…Lesser celandine extract was immediately discontinued. Using the Council for International Organizations of Medical Sciences scale (CIOMS), the type of liver injury of our case was assumed as hepatocellular (ALT > 5N and R ≥ 5) and was scored as "7: probable" (Table 1) [11] . After discontinuation of lesser celandine, rapid recovery was observed in patient and liver enzyme levels returned to normal in 3 wk.…”