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Temporal Trends in Spontaneous Reporting of Unlabelled Adverse Drug Reactions by Françoise Haramburu; Bernard Bégaud; Yola Moride is a Medicine article available to read on EtoBox.

What is Temporal Trends in Spontaneous Reporting of Unlabelled Adverse Drug Reactions about?

__Aims__ Trends in spontaneous reporting during the first years on the market were analyzed from a sample of selected drugs, with special attention to unlabelled effects. __Methods__ Ten drugs were selected giving rise to approximately 100 spontaneous reports each during the first 4 years of marketing. Case reports were identified from the national pharmacovigilance database. A bibliographical score assigned at the time of reporting was used to identify unlabelled effects. Results were expressed as reporting rates. __Results__ The average reporting rate peaked during the first year of marketing (54.6 per million treatment‐months; s.d.:62.8), then progressively decreased during the following years. Unlabelled effects represented 63% of all the spontaneous reports during the first year. __Conclusions__ Unlabelled adverse effects represent a high proportion of spontaneous reports during the early years of marketing.

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Author

Françoise Haramburu; Bernard Bégaud; Yola Moride

Publisher

John Wiley and Sons; Wiley (Blackwell Publishing); Blackwell Publishing Inc.; Wiley; Research Square (ISSN 0306-5251)

Published

1997

Language

EN

Field

Medicine (Health Sciences)