Skip to main content
Log in

Comment on: “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”

  • Letter to the Editor
  • Published:
Drug Safety Aims and scope Submit manuscript

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

The Original Article was published on 17 December 2016

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  1. 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. 2016;40(3). doi:10.1007/s40264-016-0489-7.

  2. Braillon A, Lexchin J. Off-label drug use: whose interests are served? Am J Med Qual. 2016;31:285.

    Article  PubMed  Google Scholar 

  3. Agence Française de Sécurité Sanitaire des Produits de Santé. Warning against off-label use of baclofen in the treatment of alcohol use disorders. 2001. http://ansm.sante.fr/var/ansm_site/storage/original/application/b88517d4324d10054712c930f22c464b.pdf.

  4. Degrassat-Théas A, Bocquet F, Sinègre M, Peigné J, Paubel P. The, “Temporary Recommendations for Use”: a dual-purpose regulatory framework for off-label drug use in France. Health Policy. 2015;119:1399–405.

    Article  PubMed  Google Scholar 

  5. Olivier PY, Joyeux-Faure M, Gentina T, et al. Severe central sleep apnea associated with chronic baclofen therapy: a case series. Chest. 2016;149:e127–31.

    Article  PubMed  Google Scholar 

  6. Baumann S, Toft U, Aadahl M, et al. The long-term effect of a population-based life-style intervention on smoking and alcohol consumption. The Inter99 study—a randomized controlled trial. Addiction. 2015;110:1853–60.

    Article  PubMed  Google Scholar 

  7. Beraha EM, Salemink E, Goudriaan AE, et al. Efficacy and safety of high-dose baclofen for the treatment of alcohol dependence: a multicentre, randomised, double-blind controlled trial. Eur Neuropsychopharmacol. 2016;26:1950–9.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Alain Braillon.

Ethics declarations

Funding

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

Conflict of interest

Alain Braillon was a co-investigator for the trial NCT01738282 (baclofen), but did not include patients. He is an expert for several task force groups (related to neither addiction nor psychiatry) at Agence Française de Sécurité Sanitaire des Produits de Santé.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Braillon, A. Comment on: “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, 359–360 (2017). https://doi.org/10.1007/s40264-017-0512-7

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40264-017-0512-7

Keywords

Navigation