PMID- 21098156 OWN - NLM STAT- MEDLINE DCOM- 20110208 LR - 20181201 IS - 1098-4275 (Electronic) IS - 0031-4005 (Linking) VI - 126 IP - 6 DP - 2010 Dec TI - Therapeutic acetaminophen is not associated with liver injury in children: a systematic review. PG - e1430-44 LID - 10.1542/peds.2009-3352 [doi] AB - BACKGROUND: Concern exists about the potential for liver injury with therapeutic dosing of acetaminophen in children. OBJECTIVE: We systematically reviewed the medical literature to determine the rate at which liver injury has been reported for children prescribed therapeutic doses of acetaminophen (/=24 hours and for all case reports of liver injury after therapeutic acetaminophen dosing. Trained reviewers extracted data from each report. Major and minor hepatic adverse events (AEs) were defined prospectively. Causality was assessed by using the Naranjo algorithm. RESULTS: A total of 62 studies that enrolled 32,414 children were included. No child (0% [95% confidence interval: 0.000-0.009]) was reported to have exhibited signs or symptoms of liver disease, to have received an antidote or transplantation, or to have died. Major or minor hepatic AEs were reported for 10 children (0.031% [95% confidence interval: 0.015-0.057]). The highest transaminase value reported was 600 IU/L. Naranjo scores (2-3) suggested "possible" causation. Twenty-two case reports were identified. In 9 cases, the Naranjo score suggested "probable" causation (5-6). CONCLUSIONS: Hepatoxicity after therapeutic dosing of acetaminophen in children is rarely reported in defined-population studies. Case reports suggest that this phenomenon may occur, but few reports contain sufficient data to support a probable causal relationship. FAU - Lavonas, Eric J AU - Lavonas EJ AD - Rocky Mountain Poison & Drug Center, 777 Bannock St, MC 0180, Denver, CO 80204, USA. eric.lavonas@rmpdc.org FAU - Reynolds, Kate M AU - Reynolds KM FAU - Dart, Richard C AU - Dart RC LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review PT - Systematic Review DEP - 20101122 PL - United States TA - Pediatrics JT - Pediatrics JID - 0376422 RN - 0 (Analgesics, Non-Narcotic) RN - 362O9ITL9D (Acetaminophen) SB - IM MH - Acetaminophen/*administration & dosage MH - Administration, Oral MH - Analgesics, Non-Narcotic/*administration & dosage MH - Child MH - Dose-Response Relationship, Drug MH - Drug-Related Side Effects and Adverse Reactions MH - Humans MH - Liver/*drug effects MH - Liver Failure/diagnosis/*etiology MH - Liver Function Tests EDAT- 2010/11/26 06:00 MHDA- 2011/02/09 06:00 CRDT- 2010/11/25 06:00 PHST- 2010/11/25 06:00 [entrez] PHST- 2010/11/26 06:00 [pubmed] PHST- 2011/02/09 06:00 [medline] AID - peds.2009-3352 [pii] AID - 10.1542/peds.2009-3352 [doi] PST - ppublish SO - Pediatrics. 2010 Dec;126(6):e1430-44. doi: 10.1542/peds.2009-3352. Epub 2010 Nov 22.