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Warnings on the safety of quinolones: Should Helicobacter pylori treatment prescriptions be modified?
Alertas sobre la seguridad de las quinolonas: ¿debemos modificar su prescripción en el tratamiento de la infección por Helicobacter pylori
Adrian G. McNicholla,b, Javier P. Gisberta,b,c,
Corresponding author
javier.p.gisbert@gmail.com

Corresponding author.
a Servicio de Aparato Digestivo, Hospital Universitario de La Princesa e Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain
b Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
c Universidad Autónoma de Madrid (UAM), Madrid, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In 2018&#44; the United States Food and Drug Administration &#40;FDA&#41;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">1</span></a> and the European Medicines Agency &#40;EMA&#41;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">2</span></a> issued new warnings about serious adverse effects of fluoroquinolones&#46; Both the FDA and the EMA demanded a change in the labelling of the entire class of antibiotics highlighting these new risks&#46; They also discouraged the use of fluoroquinolones for most mild and moderate infections or where there is a therapeutic alternative&#44; restricting their use exclusively to serious infections such as pneumonia&#44; anthrax and plague&#44; or other non-self-limiting infections in which the therapeutic benefit outweighs the risks&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The European Pharmacovigilance Risk Assessment Committee &#40;PRAC&#41; recently assessed the impact that potentially irreversible&#44; long-lasting&#44; disabling adverse reactions affecting the nervous and musculoskeletal systems might have on the benefit&#47;risk ratio for this drug group&#46; Accordingly&#44; the <span class="elsevierStyleItalic">Agencia Espa&#241;ola de Medicamentos y Productos Sanitarios</span> &#40;AEMPS&#41; &#91;Spanish Agency of Medicines and Medical Devices&#93; issued an informative note in October 2018 with a number of recommendations&#44; including&#58; &#40;1&#41; not to prescribe quinolone or fluoroquinolone antibiotics for the treatment of mild or self-limiting infections and &#40;2&#41; using quinolones or fluoroquinolones for the treatment of mild or moderately severe infections only when other recommended antibiotics are not effective or are not tolerated&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">It has been suggested that this warning could&#44; at least partially&#44; be in conflict with various therapeutic options currently recommended as rescue treatment after the failure of one or more drugs for the eradication of <span class="elsevierStyleItalic">Helicobacter pylori</span>&#46;<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">4&#8211;6</span></a> In the specific case of Spain&#44; these recommendations were recently issued by the &#8220;4th Consensus Conference on the management of <span class="elsevierStyleItalic">Helicobacter pylori</span> infection&#8221;&#44; in which rescue treatment with levofloxacin &#40;along with bismuth quadruple therapy&#41; was included as one of the two rescue options of choice&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">4</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Obviously&#44; we are fully on board with the health authority recommendation for responsible use of antibiotics and the need to carefully analyse the available therapeutic options and their risk&#47;benefit ratio before prescribing any drug&#46; However&#44; we feel it is important to remember that <span class="elsevierStyleItalic">H&#46; pylori</span> causes a chronic infection that can trigger serious conditions such as peptic ulcer &#40;possibly with complications&#44; such as gastrointestinal bleeding&#41; and gastric cancer&#44; and that treatment requires the combined use of several antibiotics&#46; Combined with other antibiotics&#44; quinolones play an important role in the treatment of <span class="elsevierStyleItalic">H&#46; pylori</span> infection&#44; although it has to be said that current recommendations restrict their use exclusively as rescue after the failure of other antibiotic combinations&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Following the current recommendations of the aforementioned Spanish Consensus Conference&#44;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">4</span></a> the first-line treatments have effective rates of 90&#37; or above&#46; This would therefore limit the use of fluoroquinolones to less than 10&#37; of patients&#44; particularly in view of the fact that there are other recommended rescue treatments&#44; such as the quadruple therapy with proton pump inhibitor&#44; bismuth salts&#44; tetracycline and metronidazole&#46; We must not forget that these refractory patients tend to have multiple resistance to the previously used antibiotics&#44; especially clarithromycin and metronidazole&#44; which considerably reduces the therapeutic alternatives&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">7</span></a> Therefore&#44; taking into account the virtual lack of treatment options and the risks deriving from <span class="elsevierStyleItalic">H&#46; pylori</span> infection&#44; the question is whether the frequency&#44; and in particular the severity&#44; of the adverse effects of quinolones would still lead to their use as a rescue treatment being advised against&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Fortunately&#44; some of the largest studies in the world to have assessed quinolones in the treatment of <span class="elsevierStyleItalic">H&#46; pylori</span> infection have been carried out in Spain&#46; In 2013&#44; a Spanish multicentre study was published which had involved 17 hospitals and 1000 patients treated with a proton pump inhibitor&#44; levofloxacin &#40;500<span class="elsevierStyleHsp" style=""></span>mg&#47;12<span class="elsevierStyleHsp" style=""></span>h&#41; and amoxicillin for 10 days&#44; and the rate of adverse effects was 20&#37;&#59; although 2&#46;4&#37; of these were classified as high intensity&#44; none were serious&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">8</span></a> In 2015&#44; a new Spanish series&#44; also multi-centre &#40;250 patients&#41;&#44; was published&#44; replacing levofloxacin with moxifloxacin and lengthening therapy to 14 days&#59; although the incidence of adverse effects was relatively high &#40;25&#37;&#44; 7&#46;6&#37; of high intensity&#41;&#44; no serious side effects were reported&#46;<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">9</span></a> Also published in 2015 was another Spanish multicentre study which&#44; on this occasion&#44; assessed the addition of bismuth to traditional triple therapy with levofloxacin&#44; extending the duration to 14 days and decreasing the daily dose of levofloxacin to 500<span class="elsevierStyleHsp" style=""></span>mg once a day&#46;<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">10</span></a> Adverse effects were common &#40;47&#37;&#41;&#44; but none were serious&#46; Last of all&#44; a recent meta-analysis which assessed the efficacy and safety of rescue treatment for <span class="elsevierStyleItalic">H&#46; pylori</span> with quinolones did not identify serious adverse effects in the studies it included&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">11</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">The European Registry on the management of <span class="elsevierStyleItalic">H&#46; pylori</span> infection &#40;Hp-EuReg&#41;&#44; an ambitious project led from Spain involving almost 300 hospitals in 27 countries in Europe and in which the efficacy and safety of more than 35&#44;000 eradicating treatments have been registered&#44; is a magnificent source of information on the use&#44; efficacy and safety of antibiotics used in the eradication of <span class="elsevierStyleItalic">H&#46; pylori</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">12</span></a> The data from this registry were presented recently at several European congresses and currently include a total of 3589 treatments with quinolones&#58; the incidence of adverse effects was 25&#37;&#44; only 0&#46;4&#37; of which were considered serious &#40;including mainly diarrhoea with associated time off work and vaginal candidiasis&#41;&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">To sum up&#44; in view of the results obtained in clinical practice&#44; we believe that&#44; for the time being&#44; the recommendations issued by the &#8220;4th Spanish Consensus Conference on <span class="elsevierStyleItalic">Helicobacter pylori</span> infection treatment&#8221;&#44;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">4</span></a> and by other international consensus groups&#44;<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">5&#44;6</span></a> regarding the use of fluoroquinolones as rescue treatment after eradication failure should not be modified&#46; Having said that&#44; we again insist on the need not only for responsible use of all antibiotics&#44; and quinolones in particular&#44; but also to notify all suspected adverse reactions and to remain alert to possible communications from national and international health authorities about serious adverse effects of these drugs&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0045" class="elsevierStylePara elsevierViewall">Dr Gisbert has acted as lecturer or advisor&#44; or has received research funds&#44; from MSD&#44; AbbVie&#44; Hospira&#44; Pfizer&#44; Kern Pharma&#44; Biogen&#44; Takeda&#44; Janssen&#44; Roche&#44; Sandoz&#44; Celgene&#44; Ferring&#44; Faes Farma&#44; Shire Pharmaceuticals&#44; Dr Falk Pharma&#44; Tillotts Pharma&#44; Chiesi&#44; Casen Fleet&#44; Gebro Pharma&#44; Otsuka Pharmaceutical&#44; Vifor Pharma&#44; Almirall&#44; Nycomed&#44; AstraZeneca&#44; Casen Recordati&#44; Mayoly and Allergan&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Dr McNicholl has received payment for training activities from Allergan&#44; MSD&#44; Takeda and Nycomed&#44; has been a lecturer for Allergan and Mayoly Spindler&#44; and advisor to Mayoly Spindler&#46;</p></span></span>"
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos