Monitoring the safety of antivirals. The example of the acyclovir experience.

The obligation to monitor the safety of newly introduced medicines is as old as the medical epidemiologic obligations of medicine itself. But society's expectations, the resources and methodologies for such monitoring, and the practices of the pharmacologic community have all evolved rapidly over the past decade. This report describes an extensive program of scientific epidemiologic monitoring of the safety of acyclovir during the first five years following approval. The presentation highlights the emerging field of pharmacoepidemiology, describes new and important resources and approaches for investigators concerned about drug safety monitoring, and presents safety data from the first five years of monitoring. The data thus far provide no reason for new safety concerns regarding this important antiviral; however, it is cautioned that, as in all such areas of public health protection, continued vigilance is needed.