title: Baclofen toxicity in patients with advanced nephropathy: proposal for new labeling.
abstract: BACKGROUND
  Despite several reports in the literature of baclofen toxicity in patients with renal dysfunction, the drug is being used for many patients.
  
  
  METHODS
  Herein we report a case of baclofen-induced encephalopathy in a patient with pre-end-stage renal disease and review the literature regarding the magnitude of baclofen toxicity in patients with renal insufficiency. A Medline search for studies in English was performed. Twenty-one case reports involving 41 patients (including our patient) were identified.
  
  
  RESULTS
  The majority of patients were elderly (62.5% above 60 years) males (56.3%) on dialysis (62.9%). Neurotoxicities were almost always present at presentation. Manifestations of baclofen toxicity usually started 2-3 days after starting baclofen; however, periods as long as 16 weeks have been reported. The daily dose of baclofen ranged from 5 to 60 mg with a mean dose of 20 mg. Hemodialysis (HD) was the most common treatment modality used for drug elimination (65.7%). The recovery time ranged from 2 h in patients who received HD, to 8 days with conservative treatment.
  
  
  CONCLUSIONS
  The literature does not mention a clear recommendation about baclofen safety and dose adjustment, or a minimum level of kidney function below which the drug should not be used.
authors: Division of Nephrology, James A. Haley Veterans' Hospital and University of South Florida College of Medicine, Tampa, USA. amohamed@health.usf.edu
authors: Amr
authors: A
authors: El-Husseini
authors: Alberto
authors: A
authors: Sabucedo
authors: Jorge
authors: J
authors: Lamarche
authors: Craig
authors: C
authors: Courville
authors: Alfredo
authors: A
authors: Peguero
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001418:Baclofen / Q000627:therapeutic use / Q000633:toxicity*; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001418:Baclofen