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Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France

A Letter to the Editor to this article was published on 10 February 2017



Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the ‘Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine’ (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence.


The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting.


The 2012–2013 FPVD notifications associated with baclofen OLP were extracted. The ten most frequent types of ADRs among ‘serious’ and ‘non-serious’ reports were listed. The frequency of each type of ADR was compared between CAMTEA and spontaneous reporting, and the magnitudes of the differences were assessed using standardized differences.


A total of 428 baclofen reports (1043 ADRs) were identified, among which 221 (51.64%) originated from CAMTEA. The ten most frequent ADRs in ‘serious’ reports were (1) confusion (17.3%), (2) seizures (11.5%), (3) drowsiness/sedation (11.5%), (4) agitation (10.9%), (5) coma (9.6%), (6) hallucinations (7.7%), (7) falls (7.1%), (8) behavioral disorders (5.8%), (9) withdrawal syndrome (5.1%), and (10) space–time disorientation (5.1%). A standardized difference of <0.2 was identified for six out of the ten most frequent ‘serious’ ADRs, and eight of the ten ‘non-serious’ ADRs.


A proactive regional pharmacovigilance system could collect a substantial amount of safety data on a specific OLP practice. The profile of the ADRs collected was similar to that seen in the nationwide spontaneous reporting system.

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We thank all the addiction specialists who took part in the CAMTEA system: Drs. Ali Benani, Alexandre Bonord, Thierry Briand, Catherine Carpeza, Arnaud Didier, Didier Doutriaux, Christelle Dubocage, Damien Duquesne, François Germe, Bernard Gibour, Dorothée Hennebelle, Michaël Henon, François Lefebvre, Xavier Loosfeld, Christian Maton, Lucie Molmy, Catherine Nedelec, Richard Quesney, Thierry Renaux, Cécile Richez, Marina Rose, François Sarasy, Robin Semal, Laure Spinozi, Michel Sochala, Ghassan Takkiedine, Elodie Vernalde, Véronique Vosgien, and Jacques Yguel. We also thank the network of French pharmacovigilance centers, especially the Grenoble and Paris–Fernand Widal centers, for their involvement in the national ADR reporting on off-label baclofen. We wish to direct a special thought to the late Céline Villiers for her precious work on the pharmacovigilance of baclofen in France.

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Correspondence to Benjamin Rolland.

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Benjamin Rolland was the main investigator of a study on baclofen funded by Ethypharm, and he has received fees for lectures or consultancy from Lundbeck, Indivior, AstraZeneca, Bristol-Myers-Squibb, Servier, and Ethypharm. Regis Bordet has received fees for lectures or consultancy from Lundbeck, Otsuka, and Novartis. Olivier Cottencin was an associate investigator in a clinical trial funded by Ethypharm. He has received sponsorship to attend scientific meetings from Lundbeck, BMS, Otsuka, Janssen Cilag, Reckitt Benckiser, Pfizer, and Bouchara Recordati. Sylvie Deheul worked as an independent expert for Ethypharm (independent monitoring committee of a phase I trial). Marine Auffret, Julien Labreuche, Alain Duhamel, and Sophie Gautier declare no conflicts of interest related to this article.


No sources of funding were used to assist in the preparation of this study.

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Auffret, M., Labreuche, J., Duhamel, A. et al. Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France. Drug Saf 40, 257–262 (2017).

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  • Alcohol Dependence
  • Baclofen
  • Withdrawal Syndrome
  • Spontaneous Reporting
  • Spontaneous Reporting System