F. Haramburu et al., TEMPORAL TRENDS IN SPONTANEOUS REPORTING OF UNLABELED ADVERSE DRUG-REACTIONS, British journal of clinical pharmacology, 44(3), 1997, pp. 299-301
Aims Trends in spontaneous reporting during the first years on the mar
ket were analyzed from a sample of selected drugs, with special attent
ion to unlabelled effects. Methods Ten drugs were selected giving rise
to approximately 100 spontaneous reports each during the first 4 year
s of marketing. Case reports were identified from the national pharmac
ovigilance database. A bibliographical score assigned at the time of r
eporting was used to identify unlabelled effects. Results were express
ed as reporting rates. Results The average reporting rate peaked durin
g the first year of marketing (54.6 per million treatment-months; s.d.
:62.8), then progressively decreased during the following years. Unlab
elled effects represented 63% of all the spontaneous reports during th
e first year. Conclusions Unlabelled adverse effects represent a high
proportion of spontaneous reports during the early years of marketing.