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It also blocks serotonergic 5-HT2 and 5-HT3 receptors. The most common adverse effects tend to be: drowsiness, sedation, weight gain, hyperorexia, dizziness and fatigue. Other less common side effects are asthenia, agranulocytosis, hallucinations, restlessness, and rare side effects such as pancreatitis.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">We report the case of an 83-year-old woman diagnosed with a major depressive episode 10 years earlier, who was admitted due to a 3-day history of irradiated epigastric abdominal pain, nausea, and constipation without other concomitant symptoms. The patient had had previous admissions for abdominal pain of similar characteristics. Physical examination showed: mild dehydration of mucous membranes, blood pressure 142/72<span class="elsevierStyleHsp" style=""></span>mmHg, heart rate at 86 beats per minute. The abdomen was spherical, with air-fluid noises, painful to the palpation in the epigastrium, without signs of pseudoperitonitis. Laboratory data: amylase 355<span class="elsevierStyleHsp" style=""></span>IU/dl (16–108<span class="elsevierStyleHsp" style=""></span>IU/dl); GGT: 181<span class="elsevierStyleHsp" style=""></span>IU/dl (0–50<span class="elsevierStyleHsp" style=""></span>IU/dl), lipase: 1048<span class="elsevierStyleHsp" style=""></span>IU/dL (20–190<span class="elsevierStyleHsp" style=""></span>IU/dl), 21.9<span class="elsevierStyleHsp" style=""></span>mg/dl CRP. Therefore, a CT of the abdomen was performed, showing signs of acute necrotizing pancreatitis with peripancreatic necrosis.</p><p id="par0015" class="elsevierStylePara elsevierViewall">In the pharmaceutical validation process, it was observed that she had mirtazapine, 30<span class="elsevierStyleHsp" style=""></span>mg every 6<span class="elsevierStyleHsp" style=""></span>h in her prescription, when the regimen approved in the SmPC is once a day, exceeding in this case, the maximum dose.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Mirtazapine is a drug of hepatic metabolization and renal elimination, so the drug must be adjusted in these situations.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> Our patient was an elderly, fragile and subject polypharmacy, reason why special caution was needed. It was decided to discuss the clinical situation with the responsible physicians and with her primary doctor, to adjust the dose. The patient improved her symptoms and the laboratory values of amylase and pancreatic enzymes returned to normal.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The assessment of causality is a fundamental biomedical technique for the detection of signs performed by pharmacovigilance centres through a spontaneous notification system. In addition, detecting avoidable adverse reactions is an essential practice. In our case, the Naranjo algorithm was applied for this evaluation<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a>; with a score of 6, estimating as probable the causal relationship between the drug and the adverse effect.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Several antidepressants such as amitriptyline, clomipramine, fluoxetine, venlafaxine, mirtazapine are associated with hypertriglyceridemia and pancreatitis.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> Although they are not common adverse effects, all patients had elevated amylase and pancreatic lipase in the cases described in the literature. Our patient had a dose well above the maximum dose, with which the adverse effects of the drug are intensified. However, our patient did not develop mirtazapine-induced hypertriglyceridemia or elevation of cholesterol levels, collected in clinical trials conducted on the drug.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The interest of our case is shown in the pancreatitis associated with mirtazapine, since it is a rare adverse effect, scarcely described in the literature, with a very small number of published cases.</p><p id="par0040" class="elsevierStylePara elsevierViewall">It should be noted that after the authorization and approval of the drugs by the FDA, EMA and AEMPS there is a post-marketing period in which additional rare adverse effects can be observed in authorized drugs. Real life conditions regarding the use of the drugs are different to those present in clinical trials with randomized and selected patients.</p><p id="par0045" class="elsevierStylePara elsevierViewall">In many cases, mirtazapine-induced pancreatitis may be underdiagnosed, associating it with another process. Therefore, we believe that pancreatic enzymes should be monitored in patients under treatment with mirtazapine,<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> especially when the dose is high.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Navarro Dávila MA, Shihadeh LA, Plasencia García I. Pancreatitis asociada a mirtazapina. Med Clin (Barc). 2018;150:206.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Mirtazapine associated with recurrent pancreatitis – a case report" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "A. Hussain" 1 => "J. Burke" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "J Psychopharm" "fecha" => "2008" "volumen" => "22" "paginaInicial" => "336" "paginaFinal" => "337" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0035" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Subclinical pancreatitis related to mirtazapine: a case report" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "M. Sommer" 1 => "A. Dieterich" 2 => "C. Krause" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1055/s-2001-15877" "Revista" => array:7 [ "tituloSerie" => "Pharmacopsychiatry" "fecha" => "2001" "volumen" => "34" "paginaInicial" => "158" "paginaFinal" => "159" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/11518479" "web" => "Medline" ] ] "itemHostRev" => array:3 [ "pii" => "S0886335016305776" "estado" => "S300" "issn" => "08863350" ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0040" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Can causality assessment fulfill the new European definition of adverse drug reaction? A review of methods used in spontaneous reporting" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "A. Mascolo" 1 => "C. Scavone" 2 => "M. Sessa" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.phrs.2017.07.005" "Revista" => array:6 [ "tituloSerie" => "Pharmacol Res" "fecha" => "2017" "volumen" => "123" "paginaInicial" => "122" "paginaFinal" => "129" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/28694146" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0045" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Hypertriglyceridemia acute pancreatitis, and diabetic ketoacidosis possibly associated with mirtazapine therapy: a case report" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "J. Chen" 1 => "N. Spinowitz" 2 => "M. Karwa" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:7 [ "tituloSerie" => "Pharmacotherapy" "fecha" => "2003" "volumen" => "23" "paginaInicial" => "940" "paginaFinal" => "944" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/12885107" "web" => "Medline" ] ] "itemHostRev" => array:3 [ "pii" => "S0161642007006598" "estado" => "S300" "issn" => "01616420" ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0050" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Mirtazapine: another drug responsible for drug-induced acute pancreatitis? A letter of warning" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "P. Lankisch" 1 => "H. 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