DANTROLENE-ASSOCIATED HEPATIC INJURY - INCIDENCE AND CHARACTER

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  • 1 January 1977
    • journal article
    • research article
    • Vol. 72  (4) , 610-616
Abstract
Hepatic injury during long term dantrolene sodium therapy occurred in 19 of 1044 patients (1.8%) monitored for at least 60 days. Six had icteric hepatitis (0.6%) and 3 died (0.3%). After the marketing of the drug, an additional 31 cases of dantrolene-associated liver disease were available for analysis. Of these 16 had icteric hepatitis with a favorable outcome and 11 died. The injury was mainly hepatocellular with a pattern of acute or subacute hepatic disease or chronic active hepatitis. Analysis of a total of 50 cases showed a 28% case fatality rate. All the fatalities occurred in patients > 30 yr of age and after at least 2 mo. of therapy, with 57% cases exposed for at least 6 mo. Eleven of the 14 fatalities occurred in females (P < 0.05). No cases of hepatic disease occurred in patients exposed for less than 1 mo. or < the age of 10. The majority of adverse reactions (71%) occurred between 1-6 mo. of therapy. Daily dosage of 300 mg or more is associated with higher incidence of hepatotoxic reactions and with the majority (85%) of the fatalities. This idiosyncratic hepatic injury does not appear to involve hypersensitivity to the drug. A careful assessment of the benefit-risk ratio in the therapeutic use of dantrolene sodium is proposed.

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