Safety profile of riluzole (Rilutek (R)) in the treatment of amyotrophic lateral sclerosis

Amyotrophic lateral sclerosis (ALS) is a rapidly fatal degenerative disorde r of the motoneurones which was without any effective therapy until 1997. R iluzole (Rilutek(R)) has been the first patented drug used in its specific treatment. In order to evaluate the tolerability profile of this molecule, a Pharmacovigilance study was undertaken in the Department of Neurology B a t die Montpellier University Hospital. A total of 153 patients were studied and all observed side-effects were listed in the French bank of Pharmacovi gilance. Riluzole induced one or more adverse effects in 50.3 per cent of p atients. The most frequent were gastrointestinal disturbances, hepatotoxici ty and asthenia. Dermatological, haematological, neuropsychiatric and metab olic side-effects were also reported. This study shows an acceptable safety profile for riluzole. Due to its mode of action, riluzole could potentiall y be used in the treatment of other neurodegenerative diseases involving gl utamate excitotoxicity. Subsequently, Pharmacovigilance will have to be car ried out to establish the proper use of riluzole.