Letter to the Editor
Kounis syndrome induced by ranitidine
Síndrome de Kounis inducido por ranitidina
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Our aim is to describe a case of KS triggered by an allergic reaction to ranitidine, along with a review of the reports found in the European Medicines Agency pharmacovigilance database (EudraVigilance).</p><p id="par0010" class="elsevierStylePara elsevierViewall">Male aged 66 years with no known allergies. Past medical history of type 2 diabetes mellitus, hyperlipidemia, atrial fibrillation, ex-drinker (large quantities) and ex-smoker (1 pack/day). Receiving treatment with simvastatin, metformin, bromazepam, and omeprazole. In 2015 he was diagnosed with esophagus carcinoma. He started treatment with carboplatin and paclitaxel weekly, receiving a total of 23 weekly cycles with a good response. Seven months later he presented progression and was therefore treated with the same chemotherapy scheme again. During the fourth cycle, upon commencing the administration of ranitidine and dexchlorpheniramine the patient reported burning sensation in the esophagus, breathing difficulty and loss of consciousness. An examination showed O<span class="elsevierStyleInf">2</span> desaturation 80% (SpO<span class="elsevierStyleInf">2</span> 80%), blood pressure 58/36<span class="elsevierStyleHsp" style=""></span>mmHg, and a heart rate of 155<span class="elsevierStyleHsp" style=""></span>bpm. Hydrocortisone 200<span class="elsevierStyleHsp" style=""></span>mg was administered IV to treat a suspected anaphylactic reaction. A subsequent ECG showed elevated ST, therefore lysine acetylsalicylate was administered IV, with the elevated ST remitting, and the patient was admitted to the ICU. The analytical results showed the following: troponin T 82<span class="elsevierStyleHsp" style=""></span>ng/mL (0–14<span class="elsevierStyleHsp" style=""></span>ng/mL) and D-dimer > 40,000<span class="elsevierStyleHsp" style=""></span>ng/mL (1–500<span class="elsevierStyleHsp" style=""></span>ng/mL). The echocardiogram was normal and thoracic CT scan was performed to rule out pulmonary thromboembolism, which was negative. Treatment with acetylsalicylic acid, digoxin, and enoxaparin was initiated. The patient was diagnosed with KS (vasospastic angina of probable inflammatory origin, anaphylactic shock). Upon discharge, acetylsalicylic acid and diltiazem were added. The patient was studied in the allergology clinic. The skin tests performed were positive upon pricking with ranitidine (10<span class="elsevierStyleHsp" style=""></span>mg/mL) and negative upon pricking and intradermal reaction with omeprazole and dexchlorpheniramine.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The present case was reported to EudraVigilance (worldwide identification number ES-AGEMED-126813447). The causality evaluation was performed using the algorithm from the Spanish Pharmacovigilance System (score 7)<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> and Naranjo algorithm (score 5), and both classified it as probable. A search was carried out in EudraVigilance up to January 2017 for all suspected cases of “Kounis syndrome”, as the preferred term from MEdDRA (Medical Dictionary for Regulatory Activities, version 17.1), associated with all drugs. A total of 485 individual reported cases were identified with 659 suspicious drugs. The characteristics of these cases are summarized in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">To the best of our knowledge, this is the first case relating ranitidine to KS with a positive skin test for ranitidine to be published. Although another case involving ranitidine and tramadol as the suspected drugs has been reported in EudraVigilance, it is not known which of the two caused the reaction.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> As regards the reports found in EudraVigilance, the ATC group most commonly implicated in KS is systemic anti-infectious agents (39.6% of reports), followed by the musculoskeletal system (16.8%) and the nervous system (12.6%). Amongst therapeutic groups, beta-lactams are the most commonly implicated drugs, followed by non-steroidal anti-inflammatory and antirheumatic agents, antithrombotic agents, analgesics and antipyretics, quinolones, iodinated contrast media and muscle relaxants. Most of the cases were from Turkey (26.8%), Italy (22.7%), Spain (6.2%) and Japan (6.2%). KS has mainly been reported in the south of Europe and they related this to a greater awareness of the disease amongst physicians in this region, climate, environmental conditions, excessive drug consumption or inadequacy of preventative measures.</p><p id="par0025" class="elsevierStylePara elsevierViewall">KS is an underdiagnosed disease that has become increasingly relevant in clinical practice over the past few years. Some authors recommend to carry out a systematic measurement of troponin T in patients suffering an acute allergic reaction in order to detect possible heart damage.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> The review of EudraVigilance has identified more drugs associated with KS and leads to the conclusion that the drugs most commonly involved in allergic reactions (beta-lactams and NSAIDs), tend to trigger this syndrome most frequently.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interests</span><p id="par0030" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflict of interests.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflict of interests" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Palacios-Zabalza I, Camino-Rodríguez E, Aguirre C. Síndrome de Kounis inducido por ranitidina. Med Clin (Barc). 2018;151:e51–e53.</p>" ] ] "multimedia" => array:1 [ 0 => 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 [ "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">(<span class="elsevierStyleItalic">n</span>) Number of case reports.</p>" "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">ATC code (<span class="elsevierStyleItalic">n</span>) \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">Therapeutic group (<span class="elsevierStyleItalic">n</span>) \t\t\t\t\t\t\n \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">A-Alimentary tract and metabolism (13) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Drugs for peptic ulcer and gastro-esophageal reflux disease (11)<br>-Antiemetics and antinausea agents (1)<br>-Vitamin B1 (1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">B-Blood and blood forming organs (65) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Antithrombotic agents (58)<br>-Iron preparations (4)<br>-Blood substitutes and plasma protein fractions (3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">C-Cardiovascular system (36) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Beta-blocking agents (5)<br>-Antiarrhythmic agents (4)<br>-Lipid-modifying agents (1)<br>-Angiotensin II antagonists (3)<br>-ACE inhibitors (3)<br>-Antiadrenergic agents, peripherally acting (4)<br>-Cardiac stimulants (13)<br>-Cardiac vasodilators (3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">G-Genito-urinary system and sex hormones (10) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Urological preparations, including antispasmodic agents for the genitourinary tract (2)<br>-Other gynecological products (8) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">H-Systemic hormonal preparations, excluding sex hormones and insulins (16) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Estrogens and progestins (5)<br>-Glucocorticoids (8)<br>-Anti-thyroidal preparations (3) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">J-Antiinfectives for systemic use (261) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Betalactams (196)<br>-Quinolones (34)<br>-Sulfonamides (1)<br>-Macrolides (15)<br>-Tetracyclines (1)<br>-Antifungal agents (3)<br>-Immunoglobulins (1)<br>-Direct acting antiviral agents (1)<br>-Nitroimidazole derivatives (9) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">L-Antineoplastic and immunomodulating agents (25) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Antimetabolites (8)<br>-Platinum compounds (12)<br>-Taxanes (3)<br>-Monoclonal antibodies (1)<br>-Alkylating agents (1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">M-Musculo-skeletal system (111) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Anti-inflammatory and antirheumatic products, non-steroids (95)<br>-Antigout preparations (1)<br>-Muscle relaxants (15) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">N-Nervous system (83) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Local anesthetics (14)<br>-General anesthetics (8)<br>-Analgesics and antipyretics (41)<br>-Anxiolytic agents (3)<br>-Drugs used in addictive disorders (1)<br>-Hypnotics and sedatives (2)<br>-Opioids (13)<br>-Antipsychotics (1) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">R-Respiratory system (5) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">-Expectorants (1)<br>-Antihistamines for systemic use (2)<br>-Nasal decongestants for systemic use (2) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " colspan="2" align="left" valign="top"><span class="elsevierStyleVsp" style="height:0.5px"></span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; 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