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Hepatotoxicity

Nitrofurantoin is currently one of the most common causes of drug induced liver injury. Liver injury from nitrofurantoin can cause either an acute or chronic hepatitis-like syndrome. The acute form is typically associated with a 1 or 2 week course of treatment with nitrofurantoin and is rare (~0.3 cases per 100,000 prescriptions). Acute liver injury typically presents within a few weeks of starting nitrofurantoin and can arise up to a few weeks after stopping a defined course of treatment. The pattern of liver injury is usually hepatocellular with or without jaundice, and typically is accompanied by symptoms of fever and rash. The acute injury due to nitrofurantoin usually resolves rapidly once the medication is stopped, but severe and fatal instances have been reported. In some instances, autoimmune features are present, but these are more common with the chronic presentation of nitrofurantoin hepatotoxicity. The course and outcome of acute nitrofurantoin hepatotoxicity is variable, severe forms with acute liver failure can occur, and nitrofurantoin is regularly listed as one of the major causes of acute liver failure due to medications.

The chronic form of nitrofurantoin hepatotoxicity is more common than the acute form and typically presents months to years after initiation of long term prophylactic therapy. The estimated incidence of liver injury from nitrofurantoin is approximately 1 per 1500 persons exposed. The presentation is usually insidious and marked initially by fatigue and weakness followed by dark urine and jaundice. The clinical pattern and laboratory features can mimic autoimmune hepatitis with marked elevations in serum ALT levels, increases in gamma globulin levels, and the presence of antinuclear and anti-smooth muscle antibodies. In some instances, the onset is abrupt and resembles acute hepatitis. However, immunoallergic features of fever and rash are less common than with the acute form of nitrofurantoin hepatotoxicity. Liver histology typically demonstrates features of chronic hepatitis with inflammation, interface hepatitis, focal or centrilobular bridging necrosis and variable degrees of fibrosis. Cirrhosis as a result of nitrofurantoin hepatotoxicity has been reported and, if not recognized as due to the medication, can progress to end stage liver disease. There is a female preponderance and the risk of injury appears to increase with age particularly the chronic forms.

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Likelihood score: A (well known cause of clinically apparent liver injury).

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