[Extrapyramidal toxicity caused by metoclopramide and clebopride: study of voluntary notifications of adverse effects to the Spanish Drug Surveillance System]

Unidad de Farmacología Clínica, Hospital Virgen de la Salud de Toledo.

OBJECTIVE: To clarify if there is any basis for the hypothesis that Clebopride leads to more extrapyramidal reactions than Metoclopramide. DESIGN: Observational, longitudinal, retrospective and comparative study of two series of cases. SETTING: The entire Spanish healthcare system. PATIENTS: Those notified to the Spanish Drug watch system as possibly having suffered an adverse reaction to Metoclopramide (n = 98) or Clebopride (n = 123) between 1/1/1990 and 10/6/1997. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 84.3% of suspected adverse reactions to Clebopride and 51.6% of those to Metoclopramide had a non-hospital precedence (P < 0.001). In 48.0% of suspected adverse reactions to Metoclopramide and 72.4% of those to Clebopride, there was extrapyramidal toxicity (P = 0.021). CONCLUSIONS: There is a basis for the hypothesis that Clebopride causes more extrapyramidal reactions than Metoclopramide. It was reasonable to realize a study based on this hypothesis.

PMID: 9608114 [PubMed - indexed for MEDLINE]