An inventory of medicinal products causing skin rash: Clinical and regulatory lessons
Identifieur interne : 000A19 ( Pmc/Checkpoint ); précédent : 000A18; suivant : 000A20An 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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<front><div type="abstract" xml:lang="en"><p>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.</p>
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</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Exp Ther Med</journal-id>
<journal-id journal-id-type="iso-abbrev">Exp Ther Med</journal-id>
<journal-id journal-id-type="publisher-id">ETM</journal-id>
<journal-title-group><journal-title>Experimental and Therapeutic Medicine</journal-title>
</journal-title-group>
<issn pub-type="ppub">1792-0981</issn>
<issn pub-type="epub">1792-1015</issn>
<publisher><publisher-name>D.A. Spandidos</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">31798726</article-id>
<article-id pub-id-type="pmc">6880410</article-id>
<article-id pub-id-type="doi">10.3892/etm.2019.7837</article-id>
<article-id pub-id-type="publisher-id">ETM-0-0-7837</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Articles</subject>
</subj-group>
</article-categories>
<title-group><article-title>An inventory of medicinal products causing skin rash: Clinical and regulatory lessons</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Ancuceanu</surname>
<given-names>Robert</given-names>
</name>
<xref ref-type="aff" rid="af1-etm-0-0-7837">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Dinu</surname>
<given-names>Mihaela</given-names>
</name>
<xref ref-type="aff" rid="af1-etm-0-0-7837">1</xref>
<xref rid="c1-etm-0-0-7837" ref-type="corresp"></xref>
</contrib>
<contrib contrib-type="author"><name><surname>Furtunescu</surname>
<given-names>Florentina</given-names>
</name>
<xref ref-type="aff" rid="af2-etm-0-0-7837">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Boda</surname>
<given-names>Daniel</given-names>
</name>
<xref ref-type="aff" rid="af3-etm-0-0-7837">3</xref>
<xref ref-type="aff" rid="af4-etm-0-0-7837">4</xref>
</contrib>
</contrib-group>
<aff id="af1-etm-0-0-7837"><label>1</label>
Department of Pharmaceutical Botany and Cell Biology, Faculty of Pharmacy, ‘Carol Davila’ University of Medicine and Pharmacy, 020956 Bucharest, Romania</aff>
<aff id="af2-etm-0-0-7837"><label>2</label>
Department of Public Health and Management, Faculty of Medicine, ‘Carol Davila’ University of Medicine and Pharmacy, 050463 Bucharest, Romania</aff>
<aff id="af3-etm-0-0-7837"><label>3</label>
Dermatology Research Laboratory, ‘Carol Davila’ University of Medicine and Pharmacy, 050474 Bucharest, Romania</aff>
<aff id="af4-etm-0-0-7837"><label>4</label>
Carol Medical Center, 010626 Bucharest, Romania</aff>
<author-notes><corresp id="c1-etm-0-0-7837"><italic>Correspondence to</italic>
: Professor Mihaela Dinu, Department of Pharmaceutical Botany and Cell Biology, Faculty of Pharmacy, ‘Carol Davila’ University of Medicine and Pharmacy, 6 Traian Vuia Street, Sector 2, 020956 Bucharest, Romania, E-mail: <email>mihaela.dinu@umfcd.ro</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>12</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="epub"><day>31</day>
<month>7</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>31</day>
<month>7</month>
<year>2019</year>
</pub-date>
<pmc-comment> PMC Release delay is 0 months and 0 days and was based on the . </pmc-comment>
<volume>18</volume>
<issue>6</issue>
<fpage>5061</fpage>
<lpage>5071</lpage>
<history><date date-type="received"><day>21</day>
<month>9</month>
<year>2018</year>
</date>
<date date-type="accepted"><day>27</day>
<month>5</month>
<year>2019</year>
</date>
</history>
<permissions><copyright-statement>Copyright: © Ancuceanu et al.</copyright-statement>
<copyright-year>2019</copyright-year>
<license license-type="open-access"><license-p>This is an open access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by-nc-nd/4.0/">Creative Commons Attribution-NonCommercial-NoDerivs License</ext-link>
, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.</license-p>
</license>
</permissions>
<abstract><p>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.</p>
</abstract>
<kwd-group><kwd>rash</kwd>
<kwd>summary of product characteristics</kwd>
<kwd>regulatory</kwd>
<kwd>medicinal products</kwd>
<kwd>adverse drug reaction</kwd>
</kwd-group>
</article-meta>
</front>
<floats-group><table-wrap id="tI-etm-0-0-7837" orientation="portrait" position="float"><label>Table I.</label>
<caption><p>Distribution of rash frequencies among medicinal products (per active substance) administered by oral or injectable route.</p>
</caption>
<table frame="hsides" rules="groups"><thead><tr><th align="left" valign="bottom" rowspan="1" colspan="1">Frequency</th>
<th align="center" valign="bottom" rowspan="1" colspan="1">Number</th>
<th align="center" valign="bottom" rowspan="1" colspan="1">%</th>
</tr>
</thead>
<tbody><tr><td align="left" valign="top" rowspan="1" colspan="1">Very common (≥1/10)</td>
<td align="right" valign="top" rowspan="1" colspan="1">114</td>
<td align="right" valign="top" rowspan="1" colspan="1">10.89</td>
</tr>
<tr><td align="left" valign="top" rowspan="1" colspan="1">Common (≥1/100 to <1/10)</td>
<td align="right" valign="top" rowspan="1" colspan="1">267</td>
<td align="right" valign="top" rowspan="1" colspan="1">25.50</td>
</tr>
<tr><td align="left" valign="top" rowspan="1" colspan="1">Uncommon (≥1/1,000 to <1/100)</td>
<td align="right" valign="top" rowspan="1" colspan="1">218</td>
<td align="right" valign="top" rowspan="1" colspan="1">20.82</td>
</tr>
<tr><td align="left" valign="top" rowspan="1" colspan="1">Rare (≥1/10,000 to <1/1,000)</td>
<td align="right" valign="top" rowspan="1" colspan="1">98</td>
<td align="right" valign="top" rowspan="1" colspan="1">9.36</td>
</tr>
<tr><td align="left" valign="top" rowspan="1" colspan="1">Very rare (<1/10,000)</td>
<td align="right" valign="top" rowspan="1" colspan="1">33</td>
<td align="right" valign="top" rowspan="1" colspan="1">3.15</td>
</tr>
<tr><td align="left" valign="top" rowspan="1" colspan="1">Not known<sup><xref rid="tfn1-etm-0-0-7837" ref-type="table-fn">a</xref>
</sup>
</td>
<td align="right" valign="top" rowspan="1" colspan="1">235</td>
<td align="right" valign="top" rowspan="1" colspan="1">22.45</td>
</tr>
<tr><td align="left" valign="top" rowspan="1" colspan="1">None<sup><xref rid="tfn2-etm-0-0-7837" ref-type="table-fn">b</xref>
</sup>
</td>
<td align="right" valign="top" rowspan="1" colspan="1">82</td>
<td align="right" valign="top" rowspan="1" colspan="1">7.83</td>
</tr>
<tr><td align="left" valign="top" rowspan="1" colspan="1">Total</td>
<td align="right" valign="top" rowspan="1" colspan="1">1,047</td>
<td align="right" valign="top" rowspan="1" colspan="1">100.00</td>
</tr>
</tbody>
</table>
<table-wrap-foot><fn id="tfn1-etm-0-0-7837"><label>a</label>
<p>In the up-to-date SmPC, the ‘not known’ frequency label is used when the frequency cannot be estimated from the current data. In our study, however, the same label has also been used for the older SmPC, in which the CIOMS classification has not been applied (e.g., when the SmPC mentioned rash as an example of adverse reaction occurring in ‘isolated cases’, or ‘rarely’, the ‘not known’ label was used).</p>
</fn>
<fn id="tfn2-etm-0-0-7837"><label>b</label>
<p>The ‘none’ label was used for those product/active substances for which rash or an alternative term suggesting rash as a possible adverse reaction (e.g., hypersensitivity, allergy, urticaria) was found in SmPCs.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</floats-group>
</pmc>
<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>
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