PMID- 15500412
OWN - NLM
STAT- MEDLINE
DCOM- 20051005
LR  - 20220311
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 3
IP  - 6
DP  - 2004 Nov
TI  - The tolerability of riluzole in the treatment of patients with amyotrophic 
      lateral sclerosis.
PG  - 525-34
AB  - Riluzole is the only disease-modifying drug approved for the treatment of 
      amyotrophic lateral sclerosis (ALS), in which it has been demonstrated to extend 
      survival. The overall tolerability of riluzole is good and the drug can be used 
      in all patients with ALS except those with elevated transaminase levels or active 
      liver disease. The most frequently encountered adverse events (AEs) that appear 
      to be attributed to riluzole are asthenia and nausea, observed in 18 and 15% of 
      patients taking riluzole in the randomised clinical trial programme, 
      respectively. These same AEs, albeit at a lower frequency, are also reported in 
      Phase IV observational studies and in pharmacovigilance surveys. No unexpected AE 
      clearly related to riluzole has emerged in the seven years that riluzole has been 
      in extensive use in ALS patients. The most important potential safety issue with 
      riluzole is hepatic impact with elevations of transaminases. Serum alanine 
      aminotransferase levels more than three times the upper limit of normal are 
      observed in 10 - 15% of patients. For this reason, strict monitoring of liver 
      enzymes is recommended in patients with ALS taking riluzole, and treatment is 
      contraindicated in subjects with elevated transaminases before the start of 
      treatment. There is a suspicion that riluzole may, in rare cases, cause 
      neutropenia, and physicians should be vigilant towards this risk.
FAU - Bensimon, Gilbert
AU  - Bensimon G
AD  - Hopital de la Pitie-Salpetriere, Department of Clinical Pharmacology, Assistance 
      Publique Hopitaux de Paris et Universite Paris VI, Paris, France. 
      gilbert.bensimon@infobiogen.fr
FAU - Doble, Adam
AU  - Doble A
LA  - eng
PT  - Journal Article
PT  - Review
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 7LJ087RS6F (Riluzole)
SB  - IM
MH  - Aged
MH  - Amyotrophic Lateral Sclerosis/*drug therapy
MH  - Asthenia/chemically induced
MH  - Biotransformation
MH  - Chemical and Drug Induced Liver Injury/etiology
MH  - Clinical Trials, Phase IV as Topic
MH  - Contraindications
MH  - Disease Progression
MH  - Drug Interactions
MH  - Humans
MH  - Liver Function Tests
MH  - Middle Aged
MH  - Multicenter Studies as Topic
MH  - Nausea/chemically induced
MH  - Neutropenia/chemically induced
MH  - Randomized Controlled Trials as Topic
MH  - Riluzole/adverse effects/pharmacokinetics/*therapeutic use
MH  - Risk
RF  - 40
EDAT- 2004/10/27 09:00
MHDA- 2005/10/06 09:00
CRDT- 2004/10/27 09:00
PHST- 2004/10/27 09:00 [pubmed]
PHST- 2005/10/06 09:00 [medline]
PHST- 2004/10/27 09:00 [entrez]
AID - EDS030602 [pii]
AID - 10.1517/14740338.3.6.525 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2004 Nov;3(6):525-34. doi: 10.1517/14740338.3.6.525.