[Extrapyramidal toxicity caused by metoclopramide and clebopride: study of voluntary notifications of adverse effects to the Spanish Drug Surveillance System].
OBJECTIVE
To clarify if there is any basis for the hypothesis that Clebopride leads to more extrapyramidal reactions than Metoclopramide.


METHODS
Observational, longitudinal, retrospective and comparative study of two series of cases.


METHODS
The entire Spanish healthcare system.


METHODS
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.


METHODS
None.


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.
Cuena Boy
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R
Unidad de Farmacología Clínica, Hospital Virgen de la Salud de Toledo.
Maciá Martínez
M A
MA
D000328:Adult; D000932:Antiemetics / Q000009:adverse effects*; D001549:Benzamides / Q000009:adverse effects*; D002648:Child; D003627:Data Interpretation, Statistical; D018492:Dopamine Antagonists / Q000009:adverse effects*; D005116:Extrapyramidal Tracts / Q000187:drug effects*; D006801:Humans; D008137:Longitudinal Studies; D008787:Metoclopramide / Q000009:adverse effects*; D008875:Middle Aged; D016017:Odds Ratio; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D012307:Risk Factors; D013030:Spain
D000932:Antiemetics; D001549:Benzamides; D018492:Dopamine Antagonists; C014417:clebopride; D008787:Metoclopramide
Toxicidad extrapiramidal a metoclopramida y a cleboprida: estudio de las notificaciones voluntarias de reacciones adversas al Sistema Español de Farmacovigilancia.