Abstract
In 2013 the Chilean regulatory sanitary agency issued a warning concerning dose adjustment and use restriction to avoid severe adverse effects of metoclopramide such tardive dyskinesia. To study dyskinesia type adverse effects in a population using metoclopramide. A cross sectional observational study was conducted among patients pertaining to palliative care and diabetes mellitus programs and consuming 10 mg/day or more of metoclopramide. Patients were interrogated looking for extrapiramidal signs and symptoms using a questionnaire validated by two neurologists. In 40% of diabetic patients with gastroparesia and 35% of palliative care patients, extrapyramidal adverse reactions to metoclopramide were suspected. Palliative Care patients suffered the largest number of adverse events. The period of use and individual doses of the drug were largely above Chilean regulatory agency recommendations in all cases. A significant number of patients using metoclopramide could experience extrapyramidal adverse reactions.
Highlights
In 2013 the Chilean regulatory sanitary agency issued a warning concerning dose adjustment and use restriction to avoid severe adverse effects of metoclopramide such tardive dyskinesia
Material and Methods: A cross sectional observational study was conducted among patients pertaining to palliative care and diabetes mellitus programs and consuming 10 mg/day or more of metoclopramide
Patients were interrogated looking for extrapiramidal signs and symptoms using a questionnaire validated by two neurologists
Summary
In 2013 the Chilean regulatory sanitary agency issued a warning concerning dose adjustment and use restriction to avoid severe adverse effects of metoclopramide such tardive dyskinesia. El Instituto de Salud Pública de Chile (ISP) desarrolló fuertemente las actividades de FV con la creación del Centro de Información de Medicamentos (CENIMEF), el que posteriormente se transformó en el Subdepartamento de Farmacovigilancia, dependiente de la Agencia Nacional de Medicamentos (ANAMED)[3,9], quienes dentro de sus actividades se hicieron cargo de la difusión de alertas sanitarias, haciendo eco de la información de los distintos organismos internacionales (Food and Drugs Administration [FDA], European Medicines Agency [EMA], etc). Al conocer la alerta sanitaria emitida por el ISP, donde se sugiere período de tratamiento y ajuste por peso, un grupo de químicos farmacéuticos del SSVQ decidió estudiar la presencia de RAM extrapiramidales en nuestros centros de salud asociadas al uso de metoclopramida, con el objetivo de cuantificar la prevalencia de dicho efecto en la realidad local, con miras a fundamentar el cambio en los hábitos de prescripción de este medicamento
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