Scientific Letter
Drug syrups: Errors in drug labels with possible consequences in patients with hereditary fructose intolerance
Jarabes de medicamentos: errores en ficha técnica con posibles consecuencias en pacientes con intolerancia hereditaria a la fructosa
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The consumption of fructose, sucrose, sorbitol or tagatose<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">1</span></a> for HFI patients causes severe symptoms which can lead to analytical, neurological, hepatic and renal alterations, hypoglycemia and even death.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Oral liquid presentations of drugs are classically made with sucrose (simple syrup) but the use of other sweeteners is being increased, such as hydrogenated syrups (polyalcohols) or, in a lesser extent, glucose syrups. The polyalcohols (maltitol, sorbitol, lactitol, etc.) are obtained by sugars’ catalytic hydrogenation leading to products with low caloric power. Otherwise, glucose syrups are more caloric, due to their lower sweeting power, although it can be increased with the transformation of a part of the glucose in fructose (isomerization). The food industry should indicate the amount of fructose in glucose in the definition of the ingredients if it is greater than 5%.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">3</span></a> In the pharmaceutical industry, it is mandatory to put a warning for HFI patients in leaflet and the label if the product contains sweeteners contraindicated in HFI such as fructose, sucrose, inverted sugar, sorbitol, maltitol, isomalt and lactitol<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">4</span></a> (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). We have detected errors in the denomination of glucose syrups in drug labels potentially harmful for HFI patients.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">To establish the scope, we have revised the drug label of medicines with glucose syrup between May 2013 and July 2016 using the “Prescription Nomenclator” tool of the Spanish Medicines Agency (<a href="http://www.aemps.gob.es/">www.aemps.gob.es</a>) and the information has been confirmed with each manufacturer laboratory.</p><p id="par0020" class="elsevierStylePara elsevierViewall">We detected 42 presentations commercialized with glucose syrup. We excluded 4 topical and 27 presentations which were also containing sucrose, sorbitol, maltitol, isomalt or high fructose corn syrup (3 presentations did not have the alert for HFI (11%)). We analyzed 11 presentations: 9 with liquid glucose and 2 with hydrogenated glucose syrup.</p><p id="par0025" class="elsevierStylePara elsevierViewall">In 2 presentations with liquid glucose and in 2 with hydrogenated glucose syrup, the laboratory confirms that they contain fructose and maltitol/sorbitol respectively. The formulation of these 4 presentations is syrup or oral solution; the others are tablets, capsules or vials. In one of them the laboratory indicates that the glucose syrup contains 40% of fructose. In 2 presentations from a same laboratory, we could not obtain the information of the liquid glucose composition and in another 3 (27.7%) the first response was imprecise or contained errors that required a second consultation (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). In some cases the delay in the reply has been four months.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">In conclusions, we detected very serious errors in the information about excipients in drugs labels that carry a serious safety problem for patients with HFI. The two most serious mistakes have been:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0035" class="elsevierStylePara elsevierViewall">Indicate in drug label “glucose syrup or liquid glucose” when in fact it is “glucose-fructose syrup”.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0040" class="elsevierStylePara elsevierViewall">Indicate in drug label “hydrogenated glucose syrup” as synonymous with “glucose syrup”, when in fact it is “maltitol syrup or sorbitol syrup”.</p></li></ul></p><p id="par0045" class="elsevierStylePara elsevierViewall">In addition, it has been observed that not all medications with fructose, sucrose, sorbitol, maltitol, isomalt or lactitol contain the warning or contraindication mandatory for HFI patients in packaging material, label and leaflet (according to legislation).</p><p id="par0050" class="elsevierStylePara elsevierViewall">The review has been done through an application that filters the drugs according to excipients. However, it cannot be guaranteed that all medications with glucose syrup have been checked. Therefore, these errors have been notified to the Patient Safety Program and Medication Errors of the Madrid Regional Health Sistem and to the Spanish Medicines Agency (<a href="mailto:errors.etiquetado@aemps.es">errors.etiquetado@aemps.es</a>), so that they make the necessary notifications to the pharmaceutical industry and to the health professionals.</p><p id="par0055" class="elsevierStylePara elsevierViewall">In spite of the size of the sample, both the errors in drug label and the difficulty in obtaining reliable and accurate information for the manufacturer are very striking, being necessary, in several cases, to request further clarifications, which have led to corrections with respect to the information previously issued. In some cases, if the first manufacturer's information had been considered correct, the consequence of the administration of the drug in an HFI patient could have had serious consequences on his health. We believe there is a necessity of a review process on the contents of the label in a coordinated way between regulatory agencies and the companies that manufacture and/or market these medicines.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0015">Please cite this article as: Izquierdo-García E, Escobar Rodríguez I, Moreno-Villares JM, Iglesias Peinado I. Jarabes de medicamentos: errores en ficha técnica con posibles consecuencias en pacientes con intolerancia hereditaria a la fructosa. An Pediatr (Barc). 2017;87:351–353.</p>" ] ] "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1730 "Ancho" => 1639 "Tamanyo" => 145404 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Results obtained with the information provided by the drug marketing laboratory.</p>" ] ] 1 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Excipient \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Composition \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Synonyms \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Obtaining \t\t\t\t\t\t\n \t\t\t\t</th><th class="td" title="table-head " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Suitable in HFI? \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " colspan="5" align="left" valign="top"><span class="elsevierStyleItalic">Monosaccharides</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Sorbitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Sorbitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleSmallCaps">d</span>-glucitol, <span class="elsevierStyleSmallCaps">d</span>-sorbitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Glucose hydrogenation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="5" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="5" align="left" valign="top"><span class="elsevierStyleItalic">Disaccharides</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Sucrose \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Glucose-fructose \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Saccharose, sugar, common sugar \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">From the sugar cane \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Isomalt \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Mix of maltitol and glucose-manitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Hydrogenated isomaltulose, hydrogenated palatinose \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Isomaltulose hydrogenation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Lactitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Galactose-sorbitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Lactit, lactositol, lactoboost \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Lactose hydrogenation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Maltitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Glucose-sorbitol \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Hydrogenated maltose \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Starch hydrolysate hydrogenation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="5" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="5" align="left" valign="top"><span class="elsevierStyleItalic">Syrups</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Invert sugar \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Mix of glucose and fructose \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Invert liquid sugar, invert syrup sugar \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Sucrose hydrolysis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Glucose syrup \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Mix of glucose, maltose and oligosaccharides \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Corn sugar \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Starch hydrolysis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Yes<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Maltitol syrup \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Mix of sorbitol, maltitol and hydrogenated polysaccharides \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Hydrogenated maltose syrup, hydrogenated glucose syrup with high maltose, hydrogenated starch hydrolysate \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Glucose syrup or starch hydrolysate hydrogenation \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No<a class="elsevierStyleCrossRef" href="#tblfn0005"><span class="elsevierStyleSup">a</span></a> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>High fructose corn syrup \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Glucose and fructose \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Isoglucose \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Corn starch hydrolysis and isomeration of some glucoses in fructoses (42–55%) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">No \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab1604463.png" ] ] ] "notaPie" => array:2 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "a" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Absorption is not complete. There is controversy in their tolerance.</p>" ] 1 => array:3 [ "identificador" => "tblfn0010" "etiqueta" => "b" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Check if there have fructose.</p>" ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Characteristics of excipients/sweeteners and their tolerance in HFI.<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">5,6</span></a></p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:6 [ 0 => array:3 [ "identificador" => "bib0035" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Edulcorantes en pacientes con intolerancia hereditaria a la fructosa" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "E. Izquierdo-García" 1 => "J.M. Moreno-Villares" 2 => "M. León-Sanz" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Acta Pediatr Esp" "fecha" => "2014" "volumen" => "72" "paginaInicial" => "15" "paginaFinal" => "23" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0040" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Errores congénitos del metabolismo de la fructosa" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "M. Ruiz Pons" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "LibroEditado" => array:5 [ "titulo" => "Diagnóstico y tratamiento de las enfermedades metabólicas hereditarias" "paginaInicial" => "411" "paginaFinal" => "422" "edicion" => "3<span class="elsevierStyleSup">a</span> ed." "serieFecha" => "2010" ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0045" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Directiva 2001/111/CE del Consejo, de 20 de diciembre del 2001, relativa a determinados azúcares destinados a la alimentación humana. Diario Oficial de las Comunidades Europeas, 12 de enero del 2002." ] ] ] 3 => array:3 [ "identificador" => "bib0050" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Información sobre los excipientes en el etiquetado, prospecto y ficha técnica de los medicamentos de uso humano. Circular número 2/2008 de la Agencia Española del Medicamento y Productos sanitarios (AEMPS)." ] ] ] 4 => array:3 [ "identificador" => "bib0055" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "titulo" => "Real Farmacopea Española" ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:4 [ "edicion" => "3ª ed." "fecha" => "2005" "editorial" => "Ministerio de Sanidad, Servicios Sociales e Igualdad" "editorialLocalizacion" => "Madrid" ] ] ] ] ] ] 5 => array:3 [ "identificador" => "bib0060" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Real Decreto 299/2009 de 6 de marzo. Boletín Oficial del Estado, n.° 68, de 20 de marzo del 2009. Normas de identidad y pureza de los edulcorantes utilizados en los productos alimenticios." ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/23412879/0000008700000006/v1_201711281541/S2341287917300662/v1_201711281541/en/main.assets" "Apartado" => array:4 [ "identificador" => "38181" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Scientific letters" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/23412879/0000008700000006/v1_201711281541/S2341287917300662/v1_201711281541/en/main.pdf?idApp=UINPBA00005H&text.app=https://analesdepediatria.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2341287917300662?idApp=UINPBA00005H" ]
| Year/Month | Html | Total | |
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| 2018 December | 31 | 24 | 55 |
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| 2018 October | 126 | 24 | 150 |
| 2018 September | 49 | 20 | 69 |
| 2018 August | 2 | 0 | 2 |
| 2018 July | 11 | 0 | 11 |
| 2018 June | 9 | 0 | 9 |
| 2018 May | 11 | 0 | 11 |
| 2018 April | 70 | 0 | 70 |
| 2018 March | 51 | 0 | 51 |
| 2018 February | 20 | 0 | 20 |
| 2018 January | 27 | 0 | 27 |
| 2017 November | 0 | 12 | 12 |
| 2017 October | 0 | 10 | 10 |
| 2017 September | 0 | 17 | 17 |
| 2017 August | 0 | 13 | 13 |
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| 2017 June | 0 | 18 | 18 |
| 2017 May | 0 | 17 | 17 |
| 2017 April | 0 | 119 | 119 |
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