Evaluación de señales en farmacovigilancia : metoclopramida y ansiedad

Abstract

Adverse reactions limiting the use of metoclopramide are due to their effects on the Central Nervous System (CNS). These effects occur in 10-20% of patients, their severity ranging from mild depression and nervousness, to more disabling symptoms with marked anxiety. Metoclopramide is an essential drug of frequent and habitual consumption in the population indicated as antiemetic and prokinetic; Therefore it is of great importance to identify and analyze information that determines the relationship between the use of metoclopramide and the appearance of anxiety. This research evaluates the signal that relates anxiety as an adverse event associated with the administration of metoclopramide through a systematic review. An observational, descriptive, cross-sectional pharmacovigilance study was carried out between 2009 and the first half of 2016; Investigate and analyze alerts and spontaneous notifications made to the pharmacovigilance programs of National and International Agencies of Monitoring and Control of Medicines in order to obtain information to answer the research question. During the analyzed period, a total of 483 reports were found that relate presence of anxiety during or after treatment with metoclopramide. In the age range of 21 to 30 years is the age group in which there were higher anxiety reports as a sign of adverse reaction to this drug with 11%, patients presented serious, mild and moderate events. With the data obtained in the research it is evidenced that there is information that associates a relationship Metoclopramida-Anxiety, which is made known through clinical experience through the study of case series, but not evidence of controlled clinical studies. Therefore, early signs may be too uncertain to warrant firm conclusions and regulatory actions, so additional clinical study may be necessary to test the hypothesis.