Service Pharmacie, CHRU Tours, 2, bd Tonnellé, 37044 Tours cedex, Service Hématologie, Hôpital Purpan, CHU, 1, place du Dr Baylac, 31059 Toulouse cedex 3, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d’Information sur le Médicament, Service de Pharmacologie Clinique, EA 3696, IFR 126 « Santé Société », Faculté de Médecine, 37, allées Jules-Guesde, BP 7202, 31073 Toulouse cedex 7
- Key words: rituximab, TNFα, cytokine-release syndrome, cardiac failure, pharmacovigilance
- Page(s) : 769-71
- Published in: 2005
®) is used in the treatment of refractory low-grade non-Hodgkin’s lymphoma or in case of relapse after chemotherapy. Among the different adverse reactions with this drug, the most common is a constellation of symptoms (fever, rigors and chills) that occur more frequently during administration of the first dose of drug. These symptoms could be related to a cytokine-release syndrome. We report the case of a 46 year-old patient, presenting a familial cardiomyopathy, deceased a few minutes after having developed this syndrome, at the time of the 2nd infusion of rituximab. Several hypothesis have been suggested to explain this sudden death: a cardiac failure following deterioration of the systolic function, potentially related to the negative inotropic effects of TNFα, and/or an impairment of the diastolic function following the volemic overload. The impact of the reflex “administration of monoclonal antibody/cytokine-release syndrome” was only little investigated under physiologic or pathologic conditions. In spite of a risk of adverse reactions apparently moderated compared to the other drugs used in this context, this case report underlines the need for a special attention when using rituximab among patients with cardiac risk factors (reassessment of the benefit-risk ratio, specific monitoring, pre medication). More generally, it underlines the need for a systematic and continuous identification and reporting of adverse drug reactions to the French network of regional pharmacovigilance centres.