PMID- 26987987
OWN - NLM
STAT- MEDLINE
DCOM- 20170130
LR  - 20170404
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 15
IP  - 6
DP  - 2016 Jun
TI  - Safety reports on the off-label use of baclofen for alcohol-dependence: 
      recommendations to improve causality assessment.
PG  - 747-51
LID - 10.1517/14740338.2016.1168397 [doi]
AB  - INTRODUCTION: The off-label use of high-dose baclofen (HDB) for 
      alcohol-dependence has recently spread. However, HDB has been associated with 
      numerous reports of adverse events (AEs). Pharmacovigilance reporting is supposed 
      to differentiate AEs from adverse drug reactions (ADRs), for which the causality 
      of the drug is determined using validated methods. AREAS COVERED: Since 2010, we 
      found 20 publications on baclofen-related AEs in alcohol dependence, in 
      Medline-referenced journals or national pharmacovigilance reports. We focused on 
      whether these reports used causality algorithms, and provided essential elements 
      for determining baclofen causality and excluding the involvement of alcohol and 
      other psychoactive substances or psychotropic drugs. In half of the cases, no 
      causality algorithm was used. Detailed information on baclofen dosing was found 
      in 17 out of 20 (85%) articles, whereas alcohol doses were given only in 10 (50%) 
      publications. Other psychoactive substances and psychotropic drugs were broached 
      in 14 (70%) publications. EXPERT OPINION: future publications reporting suspected 
      HDB-induced ADRs should use validated causality algorithms and provide sufficient 
      amount of contextual information for excluding other potential causes. For HDB, 
      the psychiatric history, and the longitudinal description of alcohol consumptions 
      and associated doses of psychoactive substances or psychotropic medications 
      should be detailed for every reported case.
FAU - Rolland, Benjamin
AU  - Rolland B
AD  - a Service d'Addictologie, CHU Lille , Lille , France.
AD  - b Departement de Pharmacologie Medicale INSERM U,1171 , Univ Lille , Lille , 
      France.
FAU - Auffret, Marine
AU  - Auffret M
AD  - c Centre Regional de Pharmacovigilance , INSERM U1171, CHU Lille , Lille , 
      France.
FAU - Franchitto, Nicolas
AU  - Franchitto N
AD  - d Service d'Addictologie, CHU Toulouse , France.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20160401
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (GABA-B Receptor Agonists)
RN  - H789N3FKE8 (Baclofen)
SB  - IM
EIN - Expert Opin Drug Saf. 2016 Jun;15(6):1-2. PMID: 27152897
MH  - Alcohol Drinking/prevention & control
MH  - Alcoholism/*drug therapy
MH  - Algorithms
MH  - Baclofen/administration & dosage/*adverse effects/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - GABA-B Receptor Agonists/administration & dosage/*adverse effects/therapeutic use
MH  - Humans
MH  - Off-Label Use
MH  - Pharmacovigilance
OTO - NOTNLM
OT  - Pharmacovigilance
OT  - alcohol dependence
OT  - baclofen
OT  - causality
OT  - drug safety
EDAT- 2016/03/19 06:00
MHDA- 2017/01/31 06:00
CRDT- 2016/03/19 06:00
PHST- 2016/03/19 06:00 [entrez]
PHST- 2016/03/19 06:00 [pubmed]
PHST- 2017/01/31 06:00 [medline]
AID - 10.1517/14740338.2016.1168397 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2016 Jun;15(6):747-51. doi: 10.1517/14740338.2016.1168397. 
      Epub 2016 Apr 1.