title: [Intractable diarrhoea and severe weight loss by roflumilast].
abstract: OBJECTIVE
  Roflumilast is a recently marketed drug, indicated for maintenance treatment of severe chronic obstructive pulmonary disease associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
  
  
  METHODS
  The safety data of this drug have always been subjected to controversy and concerns. The Food and Drug Administration rejected the drug after the first evaluation, asking the company to clarify the adverse reactions during the investigation process, the European Medicines Agency approved the drug including a Risk Management Plan, designed to promote a safe use of the drug.
  
  
  RESULTS
  During the first months after the marketing process, the Spanish Pharmacovigilance System has already been acquainted of several adverse events notifications; therefore, these patients may be closely monitored, mainly because of digestive and psychiatric disorders.
  
  
  CONCLUSIONS
  Here we report the case of a female patient who showed a serious digestive clinical profile and a severe weight loss, more than 25% of her initial weight, when a treatment with roflumilast was started. The suspicion of a side effect as the cause of the reported clinical profile and its resolution required 3 hospital admissions.
authors.affiliation: Servicio de Farmacia, Hospital Royo Villanova, Zaragoza, España. ohorna@salud.aragon.es
authors.forename: Oihana
authors.initials: O
authors.lastname: Horna
authors.forename: Carla
authors.initials: C
authors.lastname: Toyas
mesh_terms: D000368:Aged; D000631:Aminopyridines / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D000818:Animals; D000855:Anorexia / Q000139:chemically induced; D001549:Benzamides / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D001991:Bronchitis / Q000150:complications; D015897:Comorbidity; D003521:Cyclopropanes / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced*; D004353:Drug Evaluation, Preclinical; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects; D006212:Hallucinations / Q000139:chemically induced; D006760:Hospitalization; D006801:Humans; D010359:Patient Readmission; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D019338:Polypharmacy; D011358:Product Surveillance, Postmarketing; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D012891:Sleep Apnea Syndromes / Q000150:complications; D014839:Vomiting / Q000139:chemically induced; D015431:Weight Loss
chemical_list: D000631:Aminopyridines; D001549:Benzamides; D003521:Cyclopropanes; D010726:Phosphodiesterase Inhibitors; C424423:Roflumilast
keywords: Chronic obstructive pulmonary disease; Diarrea; Diarrhoea; Enfermedad pulmonar obstructiva crónica; Pérdida de peso; Reacción adversa; Roflumilast; Side effect; Weight loss