Letter to the Editors
Ketoconazole Allergy
Luis Felipe Ensina
, Luciana Kase Tanno, Antonio Abilio Motta, Jorge Kalil, Pedro Giavina-Bianchi
Corresponding author
Serviço de Imunologia Clínica e Alergia, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - São Paulo/SP, Brazil
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"tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "369" "paginaFinal" => "372" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig2" "etiqueta" => "Figure 2 -" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 614 "Ancho" => 989 "Tamanyo" => 48689 ] ] "descripcion" => array:1 [ "en" => "<p id="spara20" class="elsevierStyleSimplePara elsevierViewall">Estimated glomerular filtration rate before and after parathyroidectomy of the second patient</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Fabio Luiz de Menezes Montenegro, Regina Matsunaga Martin, Pedro Henrique Silveira Corrêa" "autores" => array:3 [ 0 => array:2 [ "nombre" => "Fabio Luiz" "apellidos" => "de Menezes Montenegro" ] 1 => array:2 [ "nombre" => "Regina Matsunaga" "apellidos" => "Martin" ] 2 => array:2 [ "nombre" => "Pedro Henrique Silveira" "apellidos" => "Corrêa" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S180759322202659X?idApp=UINPBA00004N" "url" => "/18075932/0000006400000004/v1_202212060657/S180759322202659X/v1_202212060657/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Letter to the Editors</span>" "titulo" => "Ketoconazole Allergy" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "373" "paginaFinal" => "374" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Luis Felipe Ensina, Luciana Kase Tanno, Antonio Abilio Motta, Jorge Kalil, Pedro Giavina-Bianchi" "autores" => array:5 [ 0 => array:4 [ "nombre" => "Luis Felipe" "apellidos" => "Ensina" "email" => array:1 [ 0 => "lfensina@yahoo.com.br" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "c1" ] ] ] 1 => array:2 [ "nombre" => "Luciana Kase" "apellidos" => "Tanno" ] 2 => array:2 [ "nombre" => "Antonio Abilio" "apellidos" => "Motta" ] 3 => array:2 [ "nombre" => "Jorge" "apellidos" => "Kalil" ] 4 => array:2 [ "nombre" => "Pedro" "apellidos" => "Giavina-Bianchi" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Serviço de Imunologia Clínica e Alergia, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo - São Paulo/SP, Brazil" "identificador" => "af1" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "c1" "etiqueta" => "*" "correspondencia" => "Tel.: 55 11 3123.5777" ] ] ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig1" "etiqueta" => "Figure 1 -" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 571 "Ancho" => 983 "Tamanyo" => 38832 ] ] "descripcion" => array:1 [ "en" => "<p id="spara10" class="elsevierStyleSimplePara elsevierViewall">Flow chart for the evaluation of type 1 hypersensitivity drug reactions.</p> <p id="spara20" class="elsevierStyleSimplePara elsevierViewall">Legend: (+) positive; (−) negative or unavailable</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="cesec10" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cestitle10">INTRODUCTION</span><p id="para10" class="elsevierStylePara elsevierViewall">Drug hypersensitivity reactions are adverse reactions to drugs that were administered at a dose that is tolerated by normal subjects, but produce symptoms that, from a clinical perspective, resemble an allergy. The revised nomenclature for allergies classifies hypersensitivity reactions to drugs as either allergic or non allergic. Drug allergies occur when immunologic mechanisms have been demonstrated.<a class="elsevierStyleCrossRef" href="#bib1">1</a></p><p id="para20" class="elsevierStylePara elsevierViewall">Allergic reactions caused by antifungal drugs are not frequently reported in clinical practice. Until now, the pathogenesis of hypersensitivity reactions to ketoconazole and other azole derivatives is unknown.<a class="elsevierStyleCrossRef" href="#bib2">2</a> Herein, we report an immediate reaction to ketoconazole and review the usefulness of a drug provocation test for diagnosis.</p></span><span id="cesec20" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cestitle20">CASE DESCRIPTION</span><p id="para30" class="elsevierStylePara elsevierViewall">A 40-year-old man began oral treatment with ketoconazole at a dosage of 400 mg per day for prophylaxis of candidiasis. Forty minutes after administration of the first dose, he developed angioedema of the face in addition to generalized urticaria. The symptoms were quickly reduced by administration of parenteral steroids and anti-histaminics. Notably, the patient had no personal or familiar history of allergies. In addition, while the patient had never taken this drug before, he had taken fluconazole approximately one year ago without noticing any adverse reactions. The patient denied the use of any other medicine at the time of taking ketoconazole and indicated that he did not have any previous episodes of urticaria or angioedema.</p><p id="para40" class="elsevierStylePara elsevierViewall">Skin prick tests with ketoconazole at a concentration of 1, 10, 20, and 40 mg/ml were all negative. A single blind placebo controlled oral challenge test with commercial ketoconazole (200 mg) was performed, showing an immediate response characterized by urticariform exanthema and angioedema within 50 minutes from ingestion of the drug. Parenteral hydrocortisone (200 mg) and diphenidramine (50 mg) were subsequently administered after which the symptoms were abated. In addition, no late response to the drug was observed.</p></span><span id="cesec30" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="cestitle30">DISCUSSION</span><p id="para50" class="elsevierStylePara elsevierViewall">Drug hypersensitivity can affect as many as 12 % of the general population, whereby non-steroid anti-inflammatory drugs and antibiotics are the most frequently implicated drugs.<a class="elsevierStyleCrossRef" href="#bib3">3</a> This case, which involves an immediate hypersensitivity to ketoconazole, is extremely rare and in fact, this is the first case study suggestive of an allergic reaction to ketoconazole to be reported in Brazil.</p><p id="para60" class="elsevierStylePara elsevierViewall">Immediate drug hypersensitivity occurs within the first hour after drug administration and is probably mediated by an IgE-dependent mechanism. The reaction, from a clinical perspective, is characterized by urticaria, angioedema, rhinitis, bronchospasm and anaphylactic shock. This patient presented an immediate reaction that was characterized by a rapid onset of the aforementioned symptoms (urticaria and angioedema).</p><p id="para70" class="elsevierStylePara elsevierViewall">The diagnosis of an immediate hypersensitivity reaction should include both <span class="elsevierStyleItalic">in vitro</span> and <span class="elsevierStyleItalic">in vivo</span> tests (Figure <a class="elsevierStyleCrossRef" href="#fig1">1</a>).</p><elsevierMultimedia ident="fig1"></elsevierMultimedia><p id="para80" class="elsevierStylePara elsevierViewall">However, the required serum specific IgE assays are only available for a few drugs, not including the azole derivatives. Additional <span class="elsevierStyleItalic">in vitro</span> tests, such as the flow cytometric basophil activation test, have not yet been validated, and their sensitivity is not 100 %.<a class="elsevierStyleCrossRef" href="#bib4">4</a></p><p id="para90" class="elsevierStylePara elsevierViewall">Skin tests are the most readily available method for physicians to test for the presence of an allergy. Currently, skin prick tests to determine if there is an allergy to a specific drug can only be validated for beta-lactam antibiotics and insulin. Due to their greater sensitivity, skin tests cannot be replaced by <span class="elsevierStyleItalic">in vitro</span> tests. The skin prick test administered in this case study was performed as described previously for ketoconazole.<a class="elsevierStyleCrossRef" href="#bib5">5</a> However, unlike the results from this previous report, our results were negative. This was probably due to the lack of a standardized procedure for administering the prick test for ketoconazole.</p><p id="para100" class="elsevierStylePara elsevierViewall">The drug provocation test (DPT) is the gold standard for the identification of an eliciting drug when allergologic tests results are negative, not available, or cannot be validated. As recommended by the European Network for Drug Allergy, the commercial preparation of the drug was administered in the same way as it was administered when the reaction occurred. The starting dose was 10 % of the therapeutic dose, with an increasing dose of 20 % of the therapeutic dose to be administered 20 minutes after the starting dose.<a class="elsevierStyleCrossRef" href="#bib6">6</a> However, the first symptoms appeared prior to the second dose, whereby the test was stopped.</p><p id="para110" class="elsevierStylePara elsevierViewall">Despite its potential risk, the DPT was useful in this particular case since ketoconazole was not a frequent cause for a reaction. In this case, avoiding ketoconazole will prevent other severe reactions. Since cross-reactivity between azole derivatives is possible, a DPT should be performed before the use of another drug from this group.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:4 [ 0 => array:2 [ "identificador" => "cesec10" "titulo" => "INTRODUCTION" ] 1 => array:2 [ "identificador" => "cesec20" "titulo" => "CASE DESCRIPTION" ] 2 => array:2 [ "identificador" => "cesec30" "titulo" => "DISCUSSION" ] 3 => array:1 [ "titulo" => "REFERENCES" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig1" "etiqueta" => "Figure 1 -" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 571 "Ancho" => 983 "Tamanyo" => 38832 ] ] "descripcion" => array:1 [ "en" => "<p id="spara10" class="elsevierStyleSimplePara elsevierViewall">Flow chart for the evaluation of type 1 hypersensitivity drug reactions.</p> <p id="spara20" class="elsevierStyleSimplePara elsevierViewall">Legend: (+) positive; (−) negative or unavailable</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "REFERENCES" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "cebibsec10" "bibliografiaReferencia" => array:6 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A revised nomenclature for allergy. An EAACI position statement from the EAACI nomenclature task force" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => """ SGO Johansson \n \t\t\t\t\t\t\t\t """ 1 => """ J O’B Hourihane \n \t\t\t\t\t\t\t\t """ 2 => """ J Bousquet \n \t\t\t\t\t\t\t\t """ 3 => """ C Bruijnzeel-Koomen \n \t\t\t\t\t\t\t\t """ 4 => """ S Dreborg \n \t\t\t\t\t\t\t\t """ 5 => """ T Haahtela \n \t\t\t\t\t\t\t\t """ ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1034/j.1398-9995.2001.t01-1-00001.x" "Revista" => array:6 [ "tituloSerie" => "Allergy" "fecha" => "2001" "volumen" => "56" "paginaInicial" => "813" "paginaFinal" => "824" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/11551246" "web" => "Medline" ] ] ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib2" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A revised nomenclature for allergy. An EAACI position statement from the EAACI nomenclature task force" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => """ JC Martinez-Alonso \n \t\t\t\t\t\t\t\t """ 1 => """ FJ Dominguez-Ortega \n \t\t\t\t\t\t\t\t """ 2 => """ MJ Fuentes-Gonzalo \n \t\t\t\t\t\t\t\t """ ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1046/j.1398-9995.2003.00287.x" "Revista" => array:6 [ "tituloSerie" => "Allergy" "fecha" => "2003" "volumen" => "58" "paginaInicial" => "1315" "paginaFinal" => "1321" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/14616111" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib3" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Self reported drug allergy in university students from São Paulo, Brazil" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => """ L Ensina \n \t\t\t\t\t\t\t\t """ 1 => """ M Amigo \n \t\t\t\t\t\t\t\t """ 2 => """ E Guzman \n \t\t\t\t\t\t\t\t """ 3 => """ R Paoli \n \t\t\t\t\t\t\t\t """ 4 => """ T Koch \n \t\t\t\t\t\t\t\t """ 5 => """ I Camelo-Nunes \n \t\t\t\t\t\t\t\t """ ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "Allergy" "fecha" => "2008" "volumen" => "63" "numero" => "Suppl. 88" "paginaInicial" => "335" "itemHostRev" => array:3 [ "pii" => "S0001731018302588" "estado" => "S300" "issn" => "00017310" ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib4" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Patients with drug reactions – is it worth testing?" 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