title: Neurological and psychiatric adverse events with prucalopride: case report and possible mechanisms.
abstract: OBJECTIVE
  Chronic constipation is very frequent in the general population. Although usually considered banal, this disorder has considerable personal, social and healthcare impact. Several studies have shown that the psychological impact exceeds that caused by rheumatoid arthritis or haemodialysis. Recently, prucalopride, a highly selective 5-HT4 receptor agonist has been shown to improve the symptoms of chronic constipation and to have a beneficial effect on social and healthcare impact. The drug was approved by the European Medicine Agency, in 2009 at a dose of 2 mg/day, 'for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief'. Neurological side effects or psychiatric disorders have not been reported previously with prucalopride. We present the case of a 61-year-old woman, who developed such adverse effects when given prucalopride for the treatment for chronic constipation.
  
  
  METHODS
  A few hours after oral administration of this drug at therapeutic dose (2 mg/day), the patient experienced life-threatening neurological effects that included visual hallucination, loss of balance and memory, disorientation, exhaustion and suicidal ideation. Analysis with the Naranjo algorithm indicated a 'possible' relationship between prucalopride and these disorders.
  
  
  CONCLUSIONS
  This is the first report of prucalopride-induced neurological side effects and psychiatric disorders with prucalopride. The absence of other similar reports suggests that prucalopride rarely causes these adverse effects.
authors.affiliation: Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco, 'Luigi Sacco' University Hospital, University of Milan, Milan, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Carnovale
authors.forename: P
authors.initials: P
authors.lastname: Pellegrino
authors.forename: V
authors.initials: V
authors.lastname: Perrone
authors.forename: S
authors.initials: S
authors.lastname: Antoniazzi
authors.forename: M
authors.initials: M
authors.lastname: Pozzi
authors.forename: A
authors.initials: A
authors.lastname: Nisic
authors.forename: E
authors.initials: E
authors.lastname: Clementi
authors.forename: S
authors.initials: S
authors.lastname: Radice
mesh_terms: D001572:Benzofurans / Q000009:adverse effects* / Q000627:therapeutic use; D002908:Chronic Disease; D003248:Constipation / Q000188:drug therapy; D005260:Female; D006212:Hallucinations / Q000139:chemically induced / Q000523:psychology; D006801:Humans; D008569:Memory Disorders / Q000139:chemically induced / Q000523:psychology; D001523:Mental Disorders / Q000139:chemically induced* / Q000523:psychology; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced* / Q000523:psychology; D009949:Orientation / Q000187:drug effects; D004856:Postural Balance / Q000187:drug effects; D012701:Serotonin / Q000502:physiology; D058828:Serotonin 5-HT4 Receptor Agonists / Q000009:adverse effects* / Q000627:therapeutic use; D059020:Suicidal Ideation
chemical_list: D001572:Benzofurans; D058828:Serotonin 5-HT4 Receptor Agonists; C406662:prucalopride; D012701:Serotonin
keywords: constipation; neurological side effects; prucalopride; psychiatric disorders