Acute liver injury related to the use of niperotidine.

BACKGROUND/AIMS: H2-receptor antagonists are widely used for the therapy of peptic disease, since they ensure a protracted and intense inhibition of gastric acidity. Niperotidine (piperonyl-ranitidine) is a new H2 blocking agent recently proposed for clinical use.

METHODS

Twenty-five cases of acute hepatitis associated with the use of niperotidine were reported in Italy between March and August 1995. Intercurrent viral infections, recent drug and alcohol consumption and blood transfusions were excluded as causes.

RESULTS

All patients showed an increase in the parameters of liver cell injury and the clinical symptoms of acute hepatitis. After withdrawal of the drug, all patients showed a good outcome, except one who developed a fulminant hepatitis and died from digestive tract bleeding.

CONCLUSIONS

The absence of other causes of acute liver injury suggests that the observed liver injury may be a niperotidine-adverse reaction. Moreover, the lack of a relationship between the dose of the drug and the degree of liver damage, the variable latent period and the rarity and unpredictability of the injury are suggestive of an idiosyncratic reaction.