Drug Safety

, Volume 40, Issue 4, pp 359–360 | Cite as

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

References

  1. 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. 2.
    Braillon A, Lexchin J. Off-label drug use: whose interests are served? Am J Med Qual. 2016;31:285.CrossRefPubMedGoogle Scholar
  3. 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. 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.CrossRefPubMedGoogle Scholar
  5. 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.CrossRefPubMedGoogle Scholar
  6. 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.CrossRefPubMedGoogle Scholar
  7. 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.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  1. 1.University HospitalAmiensFrance

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