<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0864-3466</journal-id>
<journal-title><![CDATA[Revista Cubana de Salud Pública]]></journal-title>
<abbrev-journal-title><![CDATA[Rev Cubana Salud Pública]]></abbrev-journal-title>
<issn>0864-3466</issn>
<publisher>
<publisher-name><![CDATA[Editorial Ciencias Médicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0864-34662018000100071</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Caracterización de las reacciones adversas medicamentosas de baja frecuencia de aparición]]></article-title>
<article-title xml:lang="en"><![CDATA[Characterization of low frequency of onset´s adverse drug reactions]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Santos Muñoz]]></surname>
<given-names><![CDATA[Leidy]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Jiménez López]]></surname>
<given-names><![CDATA[Giset]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alfonso Orta]]></surname>
<given-names><![CDATA[Ismary]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad de Ciencias Médicas  ]]></institution>
<addr-line><![CDATA[Matanzas ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>03</month>
<year>2018</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>03</month>
<year>2018</year>
</pub-date>
<volume>44</volume>
<numero>1</numero>
<fpage>71</fpage>
<lpage>85</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S0864-34662018000100071&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S0864-34662018000100071&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S0864-34662018000100071&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción:  Las reacciones adversas a medicamentos constituyen un problema de salud emergente, con una gran repercusión asistencial, social y económica.  Objetivo:  Caracterizar las reacciones adversas medicamentosas de baja frecuencia de aparición.  Método:  Estudio observacional, descriptivo, transversal, de serie de casos en Farmacovigilancia, a partir de la notificación espontánea de sospechas de reacciones adversas recibidas en la Unidad Coordinadora Nacional de Farmacovigilancia entre el 2004 y el 2013. La información se obtuvo de la base de datos nacional de farmacovigilancia. Se describen las reacciones adversas de baja frecuencia en cuanto a sexo, edad, tipo de efecto adverso, intensidad e imputabilidad.  Resultados:  Se evaluaron 51 523 reacciones adversas medicamentosas de baja frecuencia. Prevalecieron las clasificadas como ocasionales con 30 323 notificaciones (58,8 %). El grupo de 60 años o más fue el de mayor tasa de reporte para un valor de 29,6 por mil habitantes. Del total de casos presentados predominó el sexo femenino que representó el 65,2 %. Se afectó en mayor cuantía la piel y anejos y los fármacos con mayor implicación fueron la dipirona (29,2 %) y la penicilina rapilenta (28,9 %). Predominaron las reacciones adversas medicamentosas de baja frecuencia moderadas (58,3 %), las probables (66,5 %) y las de tipo B (50,1 %), esta última según mecanismo de producción.  Conclusiones:  La notificación de las reacciones adversas de baja frecuencia, sobre todo si son de medicamentos de reciente comercialización, permite conocer mejor su perfil de toxicidad y contribuye a reducir los riesgos en la población.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction:  Adverse drug reactions are an emerging disease, with a great social, economic and welfare impact.  Objective:  To characterize low frequency of onset´s adverse drug reactions.  Method:  Observational, descriptive, cross-sectional study of a series of cases in Pharmacovigilance, based on the spontaneous reporting of suspected adverse reactions that were received in the National Coordinating Unit of Pharmacovigilance from 2004 to 2013. The information was obtained from the national database of pharmacovigilance data. Low frequency adverse reactions are described in terms of sex, age, type of adverse effect, severity and imputability.  Results:  51 523 adverse drug reactions were evaluated. Those classified as occasional, with 30 323 notifications (58.8 %), prevailed. The group of 60 years old or more was the one with the highest reporting rate for a value of 29.6 per thousand inhabitants. Out of the total number of cases presented, female sex representing 65.2 % prevailed. The skin and appendages were more affected, and dipyrone (29.2 %) and penicillin (28.9%) were the most implicated drugs. Adverse drug reactions of moderate low frequency (58.3 %), probable (66.5 %) and type B (50,1 %) were predominant, and the last one depending on the production mechanism.  Conclusions:  The notification of low frequency adverse reactions, especially if they are of recent marketing allows a better knowledge of their toxicity profile and contributes to reduce the risks in the population.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Farmacovigilancia]]></kwd>
<kwd lng="es"><![CDATA[reacciones adversas]]></kwd>
<kwd lng="es"><![CDATA[reacciones adversas de baja frecuencia.]]></kwd>
<kwd lng="en"><![CDATA[Pharmacovigilance]]></kwd>
<kwd lng="en"><![CDATA[adverse reactions]]></kwd>
<kwd lng="en"><![CDATA[adverse reactions of low frequency]]></kwd>
</kwd-group>
</article-meta>
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</ref-list>
</back>
</article>
