Can Moduretic (a combination of amiloride and hydrochlorothiazide) cause severe liver toxicity?/nA

Fråga: Can Moduretic (a combination of amiloride and hydrochlorothiazide) cause severe liver toxicity?

A 84-year-old woman has been treated with Moduretic for four years because of mild hypertension. She has now severe hepatitis with high transaminases (above 40), increased bilirubin (about 300) and impaired coagulation. No viral ethiology has been found. Moduretic has been withdrawn and the patient is slowly recovering.

Sammanfattning: Four cases of hepatitis-like reactions in connection with Moduretic have been reported in Sweden.

Svar: The question of Moduretic and liver toxicity has previously been discussed in Drugline (1). In short, a number of cases of different hepatic reactions to either amiloride or hydrochlorothiazide or the combination have been reported to the Swedish Adverse Drug Reactions Advisory Committee. Four of these are labelled as hepatitis-like reactions. The duration of treatment varies between a few weeks up to five years. In three cases Moduretic was the only drug used, in the fourth case the patient also took Paraflex comp (acetyl salicylic acid, chlorzoxazone and dextropropoxyphene). There are also three cases of mixed liver reactions and one case of fatal liver necrosis. A follow-up search has revealed only one new report (intrahepatic cholestasis in a 58-year-old woman, who was also treated several other drugs). We have found no case-reports in Medline.

We suggest that the present case be reported to the regional centre of SADRAC, should no other explanation for the symptoms be apparent. 1 Drugline nr 07805 (year 1991) (enclosed)