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                <term xml:lang="en">Drug</term>
                <term xml:lang="en">Reversible posterior leukoencephalopathy syndrome</term>
                <term xml:lang="en">PRES</term>
                <term xml:lang="en">Posterior reversible encephalopathy syndrome</term>
                <term xml:lang="en">Posterior reversible encephalopathy syndrome PRES Reversible posterior leukoencephalopathy syndrome Drug Pharmacovigilance VigiBase</term>
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              <p>Background Posterior reversible encephalopathy syndrome (PRES) can occur in a variety of clinical conditions, such as severe hypertension, pregnancy, inflammatory diseases, hematopoietic stem cells or solid organ transplantation. Apart increased blood pressure levels and altered renal function, several drugs have been reported as potential triggering factor. These descriptions are nevertheless limited to case reports or small case series. Systematic analysis of drugs associated with PRES using global pharmacovigilance database is lacking and can be useful. Methods We performed a disproportionality analysis using VigiBase, the World Health Organization pharmacovigilance database, using the information component (IC). The IC compares observed and expected values to find associations between drugs and PRES using disproportionate Bayesian reporting. An IC 0.25 (lower end of the IC 95% credibility interval) &gt; 0 is considered statistically significant. Results Here we present an analysis of 3278 cases of PRES reported in VigiBase. These results identified 73 molecules statistically associated with PRES using full database as background with an IC 0.25 &gt; 0. Only 34% (N = 25/73) of them had this information written in the summary of product characteristics. The main drug classes involved were antineoplastic and immunomodulating agents and the drugs with the greatest number of cases were tacrolimus, cyclosporin, bevacizumab, methotrexate, and vincristine. An overall mortality of 8.1% (N = 267/3278) was identified in cases of drug-associated PRES. Conclusion These results will help clinicians identify potential suspected drugs associated with PRES and decide which drug to discontinue and eventually lead to a re-evaluation of drug labels for some molecules.</p>
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              <addrLine>85 boulevard Saint-Germain75006 Paris</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://u-paris.fr/</ref>
          </desc>
        </org>
        <org type="institution" xml:id="struct-420786" status="VALID">
          <idno type="IdRef">028021037</idno>
          <idno type="ISNI">0000000121497878</idno>
          <idno type="ROR">https://ror.org/05ggc9x40</idno>
          <orgName>Université Paris-Est Créteil Val-de-Marne - Paris 12</orgName>
          <orgName type="acronym">UPEC UP12</orgName>
          <date type="start">1970-01-01</date>
          <desc>
            <address>
              <addrLine>61 avenue du Général de Gaulle - 94010 Créteil cedex</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">http://www.u-pec.fr/</ref>
          </desc>
        </org>
        <org type="regrouplaboratory" xml:id="struct-1085123" status="VALID">
          <orgName>Institut de Cardiométabolisme et Nutrition = Institute of Cardiometabolism and Nutrition [CHU Pitié Salpêtrière]</orgName>
          <orgName type="acronym">IHU ICAN</orgName>
          <desc>
            <address>
              <addrLine>Hôpital la Pitié Salpêtrière47-83 boulevard de l’Hôpital75013 Paris 13</addrLine>
              <country key="FR"/>
            </address>
            <ref type="url">https://ihuican.org/</ref>
          </desc>
          <listRelation>
            <relation active="#struct-353778" type="direct"/>
            <relation active="#struct-300068" type="indirect"/>
            <relation active="#struct-413221" type="indirect"/>
          </listRelation>
        </org>
      </listOrg>
    </back>
  </text>
</TEI>