Epidemiology within Glaxo Wellcome (GW) has been used for quantifying medication safety issues for over a decade. Clearly, the collection and review of spontaneous reports from throughout the world is an important component of generating new safety signals. In this chapter we focus on the use of pharmacoepidemiology to address safety issues recognized during clinical development and through spontaneous reporting. Some issues addressed include:

* quantifying the expected background risk of adverse events related to an indicated condition for a new medication,

* quantifying the frequency of a serious adverse event known to be related to a new medication,

* assessing one component of the benefit-risk relationship by quantifying the frequency of a serious adverse event known to be related to some of the alternative therapies for a new medication,

* monitoring for the possibility of a new and unknown risk in pregnancies exposed to a new medication.

We illustrate these issues by describing the program of studies performed to quantify safety outcomes observed in people using lamotrigine in epilepsy. Lamotrigine was first available for epilepsy in the Republic of Ireland in 1991, and it was approved soon after within the United Kingdom. Its use spread throughout Europe shortly thereafter, and it was first available in the United States in 1995.

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