FLUCLOXACILLIN-ASSOCIATED HEPATIC-INJURY

Eleven cases of hepatic injury attributed to the intake of flucloxacil lin were reported to the Netherlands Center for Monitoring of Adverse Reactions to Drugs between 1982 and 1992. They concerned four men and seven women, with a mean age of 57 years, treated for 2-28 days with a n oral dose varying from 1500-4000 mg per day. Symptoms mostly appeare d 10 to 30 days after starting treatment with flucloxacillin. Biochemi cally, the pattern was compatible with cholestatic hepatitis in seven cases, with a mixed cholestatic-hepatocellular type of injury in one c ase, a hepatocellular pattern in two cases, and mild liver enzyme elev ations in one patient. Two patients died, one due to fatal bleeding fr om the liver after biopsy, and the second patient to a combination of hepatic and cardiac failure. The other patients recovered, on average 72 days after peaking of serum aminotransferase values. Histology in s even cases showed cholestatic hepatitis in five, with cholangitis or c holangiolitis in four of these patients. In the other two patients, th ere was centrilobular cholestasis with extensive bridging fibrosis and portal-central bridging necrosis, respectively.