THE SAFETY OF FAMCICLOVIR IN PATIENTS WITH HERPES-ZOSTER

Famciclovir is the well-absorbed oral form of the antiherpes agent pen ciclovir. Safety reports from clinical studies of more than 6500 patie nts and from spontaneous reports indicate that famciclovir is well tol erated. Safety data have been compiled for 808 patients with herpes te ster from three randomized, double-blind, clinical trials. Overall, 51 .6% of the famciclovir-treated patient population were women and 48.4% were men. The patient population ranged in age from 15 to 102 years ( mean, 51.8 years), with 55.7% aged 50 years or older. The mean duratio n of exposure to famciclovir was 6.7 days. Total daily doses ranged fr om 750 mg to 2250 mg. The most common adverse experiences reported wer e headache, nausea, and diarrhea. The frequency of adverse experiences and laboratory abnormalities (hematologic, clinical chemistry, and ur inalysis variables) was similar in both famciclovir and placebo recipi ents. Safety data from these three clinical studies demonstrate that f amciclovir is well tolerated by patients with herpes tester and has a safety profile comparable to that of placebo.