An inventory of medicinal products causing skin rash: Clinical and regulatory lessons
Identifieur interne : 000A93 ( Main/Exploration ); précédent : 000A92; suivant : 000A94An inventory of medicinal products causing skin rash: Clinical and regulatory lessons
Auteurs : Robert Ancuceanu [Roumanie] ; Mihaela Dinu [Roumanie] ; Florentina Furtunescu [Roumanie] ; Daniel Boda [Roumanie]Source :
- Experimental and Therapeutic Medicine [ 1792-0981 ] ; 2019.
Abstract
A variety of medicinal products have been associated with rash and normally this information should be available in the Summary of Product Characteristics (SmPCs). Our study aimed to investigate the frequency of rash as an adverse drug reaction, based on the information provided by SmPCs of 1,048 single active substances (international non-proprietary names) authorized in the United Kingdom. Data on rash frequency was collected from each SmPC using automated searches based on selected keywords. Data analysis was carried out using R, v. 3.4. We found that over 90% of the medicines used orally or by injection may be associated with rash as an adverse event, the most common classes being protein kinase inhibitors, anticancer medicinal products, monoclonal antibodies, biologicals, antivirals and retinoids, with high variations in rash frequency for products within the same class, but also for products with the same active substance. Analysis of SmPCs revealed the need to increase homogeneity in reporting rash frequency, by using Council for International Organizations of Medical Sciences classification, and Medical Dictionary for Regulatory Activities coding in a more standardized manner, and also the need to include more safety endpoints in clinical trials and to use better the safety results for publication and updating the SmPCs.
Url:
DOI: 10.3892/etm.2019.7837
PubMed: 31798726
PubMed Central: 6880410
Affiliations:
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Bucharest</wicri:noRegion></affiliation></author><author><name sortKey="Dinu, Mihaela" sort="Dinu, Mihaela" uniqKey="Dinu M" first="Mihaela" last="Dinu">Mihaela Dinu</name><affiliation wicri:level="1"><nlm:aff id="af1-etm-0-0-7837">Department of Pharmaceutical Botany and Cell Biology, Faculty of Pharmacy, ‘Carol Davila’ University of Medicine and Pharmacy, 020956 Bucharest, Romania</nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Department of Pharmaceutical Botany and Cell Biology, Faculty of Pharmacy, ‘Carol Davila’ University of Medicine and Pharmacy, 020956 Bucharest</wicri:regionArea><wicri:noRegion>020956 Bucharest</wicri:noRegion></affiliation></author><author><name sortKey="Furtunescu, Florentina" sort="Furtunescu, Florentina" uniqKey="Furtunescu F" first="Florentina" last="Furtunescu">Florentina Furtunescu</name><affiliation wicri:level="1"><nlm:aff id="af2-etm-0-0-7837">Department of Public Health and Management, Faculty of Medicine, ‘Carol Davila’ 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Our study aimed to investigate the frequency of rash as an adverse drug reaction, based on the information provided by SmPCs of 1,048 single active substances (international non-proprietary names) authorized in the United Kingdom. Data on rash frequency was collected from each SmPC using automated searches based on selected keywords. Data analysis was carried out using R, v. 3.4. We found that over 90% of the medicines used orally or by injection may be associated with rash as an adverse event, the most common classes being protein kinase inhibitors, anticancer medicinal products, monoclonal antibodies, biologicals, antivirals and retinoids, with high variations in rash frequency for products within the same class, but also for products with the same active substance. Analysis of SmPCs revealed the need to increase homogeneity in reporting rash frequency, by using Council for International Organizations of Medical Sciences classification, and Medical Dictionary for Regulatory Activities coding in a more standardized manner, and also the need to include more safety endpoints in clinical trials and to use better the safety results for publication and updating the SmPCs.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Hoeffel Rosa Da, I" uniqKey="Hoeffel Rosa Da I">I Hoeffel Rosa da</name></author><author><name sortKey="Resner De Moraes, M" uniqKey="Resner De Moraes M">M Resner de Moraes</name></author><author><name sortKey="Lovato, B" uniqKey="Lovato B">B Lovato</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Young, Jw" uniqKey="Young J">JW Young</name></author><author><name sortKey="Shear, Nh" uniqKey="Shear N">NH 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Meeus</name></author><author><name sortKey="Rosillon, D" uniqKey="Rosillon D">D Rosillon</name></author><author><name sortKey="Hendrickx, B" uniqKey="Hendrickx B">B Hendrickx</name></author><author><name sortKey="Ceuppens, M" uniqKey="Ceuppens M">M Ceuppens</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Rahman, Mz" uniqKey="Rahman M">MZ Rahman</name></author><author><name sortKey="Ahmed, Ds" uniqKey="Ahmed D">DS Ahmed</name></author><author><name sortKey="Mahmuduzzaman, M" uniqKey="Mahmuduzzaman M">M Mahmuduzzaman</name></author><author><name sortKey="Rahman, Ma" uniqKey="Rahman M">MA Rahman</name></author><author><name sortKey="Chowdhury, Ms" uniqKey="Chowdhury M">MS Chowdhury</name></author><author><name sortKey="Barua, R" uniqKey="Barua R">R Barua</name></author><author><name sortKey="Ishaque, Sm" uniqKey="Ishaque S">SM Ishaque</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gilbody, Js" uniqKey="Gilbody J">JS Gilbody</name></author><author><name sortKey="Fletcher, Cp" uniqKey="Fletcher C">CP Fletcher</name></author><author><name sortKey="Hughes, Iw" uniqKey="Hughes I">IW Hughes</name></author><author><name sortKey="Kidman, Sp" uniqKey="Kidman S">SP Kidman</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Roumanie</li></country></list><tree><country name="Roumanie"><noRegion><name sortKey="Ancuceanu, Robert" sort="Ancuceanu, Robert" uniqKey="Ancuceanu R" first="Robert" last="Ancuceanu">Robert Ancuceanu</name></noRegion><name sortKey="Boda, Daniel" sort="Boda, Daniel" uniqKey="Boda D" first="Daniel" last="Boda">Daniel Boda</name><name sortKey="Boda, Daniel" sort="Boda, Daniel" uniqKey="Boda D" first="Daniel" last="Boda">Daniel Boda</name><name sortKey="Dinu, Mihaela" sort="Dinu, Mihaela" uniqKey="Dinu M" first="Mihaela" last="Dinu">Mihaela Dinu</name><name sortKey="Furtunescu, Florentina" sort="Furtunescu, Florentina" uniqKey="Furtunescu F" first="Florentina" last="Furtunescu">Florentina Furtunescu</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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