SAFETY OF FAMCICLOVIR IN PATIENTS WITH HERPES-ZOSTER AND GENITAL HERPES

Safety reporting from individual ongoing and completed clinical studie s has demonstrated that famciclovir, the well-absorbed oral form of th e antiherpesvirus agent penciclovir, has been well tolerated by more t han 3,000 individuals worldside. An integrated safety evaluation has b een performed and includes over 1,600 patients from 11 completed, rand omized, double-blind clinical trials and 2 open trials. The famciclovi r population consisted of 816 herpes tester patients (four trials), 40 9 patients with acute genital herpesvirus infections (seven trials), a nd 382 patients from two genital herpes suppression studies. Overall, the famciclovir-treated patient population was 57.7% female and ranged in age from 15 to 102 years (mean, 42.6 years), with 31.2% aged 50 ye ars or more and 15.7% aged 65 years or more. The mean duration of expo sure to famciclovir was 28.8 days (5.8 days excluding suppression stud ies). The total daily doses ranged from 125 mg to 2.25 g. The most com mon adverse experiences reported as related to study medication (famci clovir and placebo) were headache, nausea, and diarrhea. The frequenci es of adverse experiences and laboratory abnormalities (hematology, cl inical chemistry, and urinalysis parameters) were similar in both famc iclovir and placebo recipients. Thus, safety data from the analysis of 13 completed clinical studies demonstrate that famciclovir is tolerat ed well by patients with either herpes tester or genital herpes and ha s a safety profile comparable to that of placebo.