PMID- 27747729
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240325
IS  - 2199-1162 (Print)
IS  - 2198-977X (Electronic)
IS  - 2199-1162 (Linking)
VI  - 2
IP  - 1
DP  - 2015 Dec
TI  - Enoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA 
      Adverse Event Reporting System (FAERS).
PG  - 17
LID - 17
AB  - Anticoagulants are a well known cause of drug-induced liver injury (DILI). We 
      recently encountered a 45-year-old male who developed DILI during treatment with 
      enoxaparin, a low-molecular-weight heparin (LMWH), for dural venous thrombosis. 
      The man received enoxaparin 80 mg subcutaneously, twice daily. After 4 days, the 
      patient was asymptomatic but he developed liver aminotransferase elevations: AST 
      340 U/L and ALT 579 U/L. Investigation revealed an R ratio of 19.9 by day 5 and a 
      Roussel Uclaf Causality Assessment Method score of 10, giving a high probable 
      likelihood that enoxaparin was the cause of hepatic injury. Enoxaparin was 
      discontinued on day 7, and 1 week later AST and ALT had decreased to 61 and 
      273 U/L, respectively. This case prompted a literature search and a review of the 
      FDA Adverse Event Reporting System (FAERS) database for the range of hepatic 
      adverse events (HAEs) associated with this class. A MEDLINE/PubMed search was 
      conducted using DILI terms and cross-referenced with the anticoagulant classes. A 
      Freedom of Information Act (FOIA) request was also made to identify adverse 
      events (AEs) associated with enoxaparin in FAERS. Case type, severity of outcome, 
      and demographic information were analyzed. Five publications have reported DILI 
      with enoxaparin. Trial data found elevations in ALT >3 times the upper limit of 
      normal (ULN) for unfractionated heparins (UFH) and LMWH in 8 and 4-13 % of 
      subjects, respectively. However, liver injury in all cases was mild, 
      self-limited, and asymptomatic. Our FOIA request yielded 8336 adverse events 
      related to enoxaparin over a 14-year period (Jan 2000-Sept 2014). Specific HAEs 
      were found in 4 % of reports, but all were described with other serious adverse 
      events. The reported outcomes of hospitalization (75 %), death (17 %), and 
      life-threatening medical events (5 %) were likely due to other related serious 
      adverse events such as hemorrhage (28 %) and thrombocytopenia (11 %). We conclude 
      that LMWH-related liver injury is uncommon and reversible. The mechanism of liver 
      injury is not known, although an idiosyncratic effect is postulated. Although the 
      FAERS database lists hepatic injury in 4 % of all enoxaparin-related AEs, it 
      appears that serious outcomes are related to non-hepatic events.
FAU - Hahn, Katherine J
AU  - Hahn KJ
AD  - Department of Internal Medicine, Medstar Georgetown University Hospital, 3800 
      Resevoir Road, NW, PHC Floor #5, Washington, DC, 20007, USA. 
      katherine.j.hahn@medstar.net.
FAU - Morales, Shannon J
AU  - Morales SJ
AD  - Department of Internal Medicine, Medstar Georgetown University Hospital, 3800 
      Resevoir Road, NW, PHC Floor #5, Washington, DC, 20007, USA.
FAU - Lewis, James H
AU  - Lewis JH
AD  - Department of Gastroenterology and Hepatology, Medstar Georgetown University 
      Hospital, Washington, DC, USA.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - Switzerland
TA  - Drug Saf Case Rep
JT  - Drug safety - case reports
JID - 101674544
PMC - PMC5005670
EDAT- 2016/10/18 06:00
MHDA- 2016/10/18 06:01
PMCR- 2015/11/17
CRDT- 2016/10/18 06:00
PHST- 2016/10/18 06:00 [entrez]
PHST- 2016/10/18 06:00 [pubmed]
PHST- 2016/10/18 06:01 [medline]
PHST- 2015/11/17 00:00 [pmc-release]
AID - 10.1007/s40800-015-0018-0 [pii]
AID - 18 [pii]
AID - 10.1007/s40800-015-0018-0 [doi]
PST - ppublish
SO  - Drug Saf Case Rep. 2015 Dec;2(1):17. doi: 10.1007/s40800-015-0018-0.