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To the Editor: Spontaneous reporting remains the most used and efficient method of identifying new adverse drug reactions (ADRs) in the postmarketing phase.¹ We assessed the magnitude of underreporting for serious ADRs in France by using data from 3 field pharmacoepidemiological studies.

Methods

The 3 studies we selected for analysis^2-4 were published in peer-reviewed journals, conducted in France in 1997 through 1998, and based on a representative sample of the source population. Each study was intended to estimate the number of hospitalizations caused by drugs. Therefore, estimating the magnitude of underreporting was possible by comparing the reported ADRs to the number of cases spontaneously reported to the French pharmacovigilance system during the same period and within the same territory.

Results
In 1997, Lacoste-Roussillon et al² studied the incidence of serious ADRs observed by a representative random sample of 200 general practitioners in the Aquitaine Region (southwestern France). In this prospective study, . . . [Full Text of this Article]

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