SAFETY OF ACYCLOVIR - A SUMMARY OF THE 1ST 10 YEARS EXPERIENCE

The era of pharmacoepidemiology has introduced profound changes in the ability of the sector to monitor the post-marketing safety of new pro ducts. We report on the population-based assessment by Wellcome of the safety of Zovirax reflected in a program of unprecedented scope, dive rsity, and, most important, utility. The program couples epidemiologic intelligence-analysis of adverse experience reports arising spontaneo usly from practice and reported directly to the manufacturer, regulato rs, or in the published literature-with more structured formal epidemi ologic research approaches. Taken together, the absence of major medic al problems emerging from the monitoring system for spontaneous report s from the medical practice experience among over 20 million persons t reated worldwide over the past decade, complemented by the similar abs ence of 'signals'' from structured epidemiologic studies closely monit oring the experience of over 50,000 patients, constitutes a persuasive body of information concerning the general safety of this important t herapeutic intervention. (C) 1993 Wiley-Liss, Inc.