Troubles extrapyramidaux sous véralipride (Agréal®), traitement symptomatique des bouffées de chaleur : à propos de 17 cas

Abstract: Purpose. – Extrapyramidal disorders associated with veralipride therapy are rarely reported and often due to a drug misuse. Methods. – We evaluated cases of extrapyramidal disorders associated with veralipride. Cases were extracted from the regional pharmacovigilance centre of Amiens database. From January 1, 1995 to September 30, 2004, cases were selected on the basis of the occurrence of extrapyramidal disorders under veralipride therapy. Results. – Seventeen cases of veralipride-induced extrapyramidal disorders were found. They consist of 16 menopausal women and one old man with LH-RH antagonist-induced hot flushes. Mean age was 61 years (48–73). Adverse effects were acute dyskinesia (n =2) or parkinsonian syndrome, which occurred after several months or years of treatment (n =15). Parkinsonism was associated with other extrapyramidal symptoms in 8 cases: tardive dyskinesia (n =6), postural tremor (n =3), myoclonia (n =1), and trunk dystonia (n =1). In all cases, outcome was favorable after drug discontinuation. In most cases the tablet-free interval was not respected: this may lead to prolonged striatal D2 receptors blockade. It must be added that the diagnosis was often delayed and patients were considered as suffering from idiopathic Parkinson''s disease. Conclusions. – Prescribers should be aware that veralipride is a neuroleptic and could induce potentially severe extrapyramidal disorders. Increase veralipride prescription is expected due to the recent restriction of hormonal replacement therapy for menopause. The physicians should also use veralipride according to the Summary of the Product Characteristics. [Copyright &y& Elsevier]