A part of this study was presented as an oral presentation at the 2012 French Congress of Physiology, Pharmacology and Therapeutics (4-6 April, Dijon, France).
Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France?†
Article first published online: 7 SEP 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 21, Issue 12, pages 1289–1294, December 2012
How to Cite
Paludetto, M.-N., Olivier-Abbal, P. and Montastruc, J.-L. (2012), Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France?. Pharmacoepidem. Drug Safe., 21: 1289–1294. doi: 10.1002/pds.3333
- Issue published online: 6 DEC 2012
- Article first published online: 7 SEP 2012
- Manuscript Accepted: 16 JUL 2012
- Manuscript Revised: 5 JUL 2012
- Manuscript Received: 15 MAR 2012
- adverse drug reaction;
- drug withdrawal
The objective of our study was to determine the nature of scientific evidence leading to drug withdrawal for safety reasons in France (between 2005 and 2011).
Drugs (i.e., active ingredients) withdrawn were identified from the Web site of the French Health Products Agency. Additional information allowed us to classify these withdrawals according to the nature of evidence as clinical trials (CT), case reports/case series (CR/CS), case–control studies (CC), cohort, animal, or observational studies.
A total of 22 active ingredients were withdrawn from the French market between 2005 and 2011. The nature and type of adverse drug reactions (ADRs) leading more frequently to drug withdrawal were cardiovascular (10-fold), neurological (5-fold), or hepatic, cutaneous, or psychiatric (3-fold each) ADRs. CR (19/22; 86.4%) and CT (13/22; 59.1%) were the most frequently involved methods. In 5 of 22 (23%) cases, CR were the sole evidence. However, 68% (15/22) of regulatory decisions were based on multiple sources of evidence: For example, data from CR + CT were used in eight cases. CC or cohort studies were used in only five cases.
This study underlines that spontaneous reporting remained the most important source of drug withdrawals between 2005 and 2011. However, its relative importance decreased in comparison with that in 1997–2004. The importance of pharmacoepidemiological methods slightly increased but remained low. Finally, regulatory authorities seem to have more frequently based their safety decisions on multiple sources of evidence than before. Copyright © 2012 John Wiley & Sons, Ltd.