Related Experiment Video
Updated: Aug 11, 2026

Tracking Drug-induced Changes in Receptor Post-internalization Trafficking by Colocalizational Analysis
Published on: July 3, 2015
Temporal trends in spontaneous reporting of unlabelled adverse drug reactions
F Haramburu1, B Bégaud, Y Moride
1Centre de Pharmacovigilance, CHU, Université Victor Segalen, Bordeaux, France.
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 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.
More Related Videos
Related Concept Videos
Drug Regulation
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Therapeutic Drug Monitoring: Affecting Factors
Drug Toxicity: Overview
Drug Toxicity: Risk factors
Pharmaceutical Poisoning: Potential Scenarios

