arznei-telegramm 2004; 35: 86

 
 

Naftidrofuryl (e.g. NAFTILONG) and liver damage: A 42 year old female patient, who had been hospitalised for cholelithiasis with biliary colic, was, by chance, found to have serious hepatitis, with increased liver enzymes (AST up to 1500 u/l) and bilirubin (total bilirubin 3.42 mg/dl), attributed to the use of naftidrofuryl. After withdrawal of the vasodilator, which had been prescribed for tinnitus since two weeks, the liver enzymes declined. According to the assessment of the attending physicians, obstruction of the bile duct due to the migration of a stone could not have resulted in such an increase in liver enzymes (NETZWERK-report 13.303). NAFTILONG is approved for the treatment of intermittent claudication; its benefit is, however, doubtful for this indication (a-t 2000; 31: 87). Other cases on liver damage are reported in literature. In a 44 year old female patient the use of naftidrofuryl resulted in granulomatous hepatitis with jaundice, dizziness, loss of appetite, darkening in colour of the urine, increased liver enzymes and bilirubin, which was wrongly diagnosed and resulted in an unnecessary cholecystectomy. Within three months after withdrawal from treatment the liver values returned to normal (CHOLONGITAS, E. et al.: Am. J. Gastroenterol. 2003; 98: 1448-50). In a 60 year old female patient with typical complaints of hepatitis, who was also found to have gall stones, naftidrofuryl was considered to be the reason for the liver damage with pronounced centrilobular necrosis (DE CAESTECKER, J.S., HEADING, R.C.: Postgrad. Med. J. 1986; 62: 309-10). Whilst the Rote Liste 2004 mentions only an "isolated case" with liver cell necrosis, the summary of product characteristics states that hepatitis, cholestatic icterus and an increase in liver enzymes can occur in "very rare" cases (Merck: SPC DUSODRIL, edition: Febr. 2003).



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