This registry is an observational registry collecting information on cases of SJS, TEN, and erythema multiforme with mucosal involvement throughout Germany. They make every effort to identify all hospitalized cases of SJS and TEN within the country, and they collect information on drug exposures prior to the event. Each possible case is reviewed by an expert group to assign a diagnosis. For estimation of rates, they utilize prescription data (defined daily doses, or DDDs) as a surrogate for the number of people exposed to each medication, and initially when lamotrigine was first marketed in Germany their data seemed to demonstrate that the rate based on DDD denominators for SJS or TEN in lamotrigine was substantially higher than other anticonvulsants. However, as the market matured and the percentage of total use which was new use declined, the ratio of the number of cases to the number of DDDs declined (Schlingmann, 2000). This observation is consistent with the concept that for mature medications the rates of SJS and TEN are substantially underestimated because the denominators are overestimated with the inclusion of long-term use. Nevertheless, given that the numbers of SJS or TEN cases failed to increase while the use of lamotrigine was increasing, it is likely that other factors, such as the reduction of the lamotrigine starting dose, may have also contributed to this decline in rate.
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