[Hepatic toxicity of nitrofurantoin. Cases reported to the Center for Monitoring Adverse Drug Reactions 1968-1998]

Forty-four cases of nitrofurantoin-associated hepatic injury were reported to the Danish Center for Monitoring of Adverse Drug reactions from 1968 to 1998. Forty-one were women with a median age of 69 years. They had been treated with nitrofurantoin for median one year (two days-seven years), and all had biochemical and clinical signs of hepatitis. In five cases the injury had been provoked by a rechallenge. Twenty-seven liver biopsies showed an equal amount of acute and chronic histopathological changes. Cirrhosis was diagnosed in seven cases. Four died in liver failure; the others apparently recovered without long-term symptoms. In rare cases, nitrofurantoin can cause toxic hepatitis. Apparently elderly women in long-term treatment are more sensitive to develop this adverse reaction. The drug should be withdrawn if the patient shows any signs of hepatitis during treatment and the patient should be informed about the possible relationship to nitrofurantoin exposure. Rechallenge should not be performed.