Flucloxacillin and hepatic injury

From July 1980 to May 1994, the Adverse Drug Reactions Advisory Committee (ADRAC) has received 310 reports of adverse hepatic effects associated with flucloxacillin. The reports were predominantly cholestatic, with large increases in serum bilirubin, up to 30 times the upper limit of normal. Seventeen of the 310 reports to ADRAC were documented as fatal, and although the hepatic reaction was the likely cause of death in only nine cases, it was an important contributing factor in the other eight. Flucloxacillin is a valuable antibiotic, being the drug of choice for serious infections with methicillin sensitive Staphylococcus aureus and Staphylococcus epidermidis. Because of uncommon but potentially severe hepatic reactions, flucloxacillin should only be used for the treatment of serious staphylococcal infections. (non-author abstract)