Drug-induced Restless Leg Syndrome: a study in the French Pharmacovigilance Database.

SANTIAGO PEREZ-LLORET; JEAN-LOUIS MONTASTRUC; OLIVIER RASCOL

Toronto, Canada

Congreso; Congreso Internacional de Movimientos Anormales; 2011

Objective: We investigated RLS notifications to the French Pharmacovigilance database (FPDB) according tosuspected drug, age, sex or year of report.Background: Restless Leg Syndrome (RLS) can be idiopathic or secondary to pregnancy, iron deficiency orchronic renal failure. Recently, some cases apparently resulting from drugs have been reported.Methods: The FPDB contains more than 300,000 spontaneous reports of Adverse Drug Reactions (ADRs) since1984. We selected all ADRs reports from 1st January 1984 to 31st December 2009 coded by MeDRA as RLS.Dates of reports, demographics of the patients as well as suspected medications were extracted. A neurologistvalidated RLS diagnosis from case descriptions into de FPDB.Results: 26 reports were found. Four cases were excluded because of alternative diagnosis (3 peripheralneuropathy, 1 allergic reaction). Fourteen out of the other 22 cases were females (64%). Median age was 57(range: 22-91), 36% of cases were between 50-60 years old. On average 1 case/year was reported from 1990to 2007 and 4 cases/year since 2008. Most frequently suspected drugs were antidepressants (n=6, 27%, 4serotonin antagonists, 1 imprimanic, 1 selective serotonin-reuptake inhibitor), neuroleptics (n=4, 18%) oropioid analgesics withdrawal (n=2, 9%) or therapy (n=2, 9%). Other suspected drugs were: ropinirole,trimetazidine, ornithine, nicergoline, nitrofurantoine, fosfomycine, docetaxel, leuproreline, valpromide, oxybate,inhaled beclometasone/formoterol, alanine (1 case each).Conclusions: Drug-induced RLS involved most frequently antidepressants, neuroleptics or opiod analgesics. Asurge in reporting frequency was noted in 2008-2009, probably reflecting increased recognition of thissyndrome. Female sex predominance and RLS onset median age match those of secondary RLS.