Background/aims: Chronic evolution after drug-induced liver injury (DILI) has been reported. How often this leads to liver-related morbidity and mortality is unexplored.
Methods: Patients who survived DILI and concomitant jaundice reported to the Swedish Adverse Drug Reaction Advisory Committee (1970-2004) were linked to the Swedish Hospital Discharge and Cause of Death Registries.
Results: Among the 712 survivors, 27 could not be retrieved but 685 patients could be linked to the registries, 392 females (57.2%) and 293 males (42.8%) median age 58 (41-74), a mean follow-up of 10 years. A total of 23/685 (3.4%) patients had been hospitalized for liver disease and 5 had liver-related mortality. Eight patients developed cirrhosis (7 decompensated, 5 died), 5 had "cryptogenic" cirrhosis in which DILI might have played a role in this development. Duration of therapy before DILI was longer in patients with liver-related morbidity/mortality (135+/-31 days vs. 53+/-3; p<0.0001). Autoimmune hepatitis developed in 5/23 (22%), all of female gender after a mean of 5.8 years.
Conclusions: Development of clinically important liver disease after severe DILI associated with jaundice is rare after acute DILI. However decompensated "cryptogenic" cirrhosis developed in some patients with fatal outcome in which DILI might have played a role in this development.