Assessing causality by means of the Naranjo scale in a paediatric patient with life threatening respiratory failure after alemtuzumab administration: a case report

Abstract

Background Alemtuzumab is a T cell depleting antibody agent used as induction immunosuppressant therapy in solid organ transplant recipients. In addition, it is being increasingly used to treat severe or glucocorticoid-resistant graft rejection. Despite the effectiveness of the treatment, severe adverse events have been reported related to alemtuzumab administration. We present a similar event illustrating the severity of this adverse drug reaction (ADR) and we highlight the structure causality assessment provides in approaching such a case. Case presentation We report a case of life-threatening respiratory failure after alemtuzumab administration in a 17 year old paediatric kidney transplant recipient. He developed near fatal severe respiratory and circulatory failure based on acute respiratory distress syndrome (ARDS) with diffuse alveolar oedema and haemoptysis hours after his second alemtuzumab administration. As it was questionable whether alemtuzumab could be regarded as the origin of his reaction and in order to assess the causality of this reaction as well as to structure clinical reasoning, we applied a widely used ADR probability scale to systematically review our case. Discussion and conclusions Our case shows a severe ADR after alemtuzumab administration. It illustrates the importance of proper causality assessment, the structure it provides and the benefit of a clinical pharmacology consultation when a severe reaction is suspected to be an ADR. By taking our case as an example, we demonstrate the added value of structured causality assessment to clinical reasoning and in generating differential diagnoses.

Pearls and Pitfalls in Pediatric Kidney Transplantation After 5 Decades

“…In total, 36 patients received pulsatile methyl prednisone during follow-up. We have reported one case of life-threatening respiratory failure after alemtuzumab administration (217).…”

A Case Report of Intratesticular Hematoma in a Patient with Reiter’s Syndrome

“…Thus, the assessment may only result in a possible or probable causality score and should never be considered definitive (final score ≥ 9). In our case, caution is necessary when interpreting the final score, and dismissing it as only a probable ADR without considering its severity should be avoided [ 13 ]. In addition, the case has been notified to a pharmacovigilance system (Taiwan National Adverse Drug Reactions Reporting System); the notification number (Worldwide ID) of the ADR mentioned in the article is “TW-TFDA-TDS-1120003247”.…”