SAFETY EVALUATION OF CHRONIC FLUCONAZOLE THERAPY

The possible adverse effects of chronic, high-dose fluconazole therapy are detailed from analysis of a multicenter, dose-escalating study of the therapy of invasive mycoses, Ninety-three adult patients were stu died, 48 of these received greater than or equal to 6 months therapy a nd 20 received greater than or equal to 1 year. Fifty-eight patients r eceived greater than or equal to 300 mg/day, and 7 received greater th an or equal to 600 mg/day, One patient received 1,997 g over 86 months . Twenty-seven percent experienced possible symptomatic side effects, which resulted in 2 patients discontinuing therapy, and 42% had asympt omatic laboratory abnormalities, none of which were progressive. Heada che, hair loss and anorexia were the most common symptoms experienced (each by 3% of patients), and eosinophilia and aspartate aminotransfer ase increases were the most common laboratory findings (12 and 10%, re spectively), Fluconazole appears well tolerated and safe in these dose s and durations.