Liquid formulation of ifosfamide increased risk of encephalopathy: A case-control study in a pediatric population
- Hillaire-Buys, Dominique
- Mousset, Mégane
- Allouchery, Marion
- Azzouz, Brahim
- Babin, Marina
- Bellet, Florelle
- Béné, Johana
- Default, Anne
- Durrieu, Genevieve
- Géniaux, Hélène
- Grandvuillemin, Aurélie
- Gras-Champel, Valérie
- Jantzem, Hélène
- Lambert, Aude
- Lepelley, Marion
- Massy, Nathalie
- Petitpain, Nadine
- Rocher, Fanny
- Sanchez-Pena, Paola
- Sassier, Marion
- Simon, Corinne
- Triquet, Louise
- Valnet-Rabier, Marie-Blanche
- Veyrac, Gwenaëlle
- Faillie, Jean-Luc
- Zenut, Marie-Christine
DOIAbstract
International audienceBACKGROUND:Several clusters of encephalopathy occurred after the market change from Holoxan® (ifosfamide lyophilized powder) to Ifosfamide EG® (liquid formulation) and justified a formal survey in 2015. In June 2016, the regulatory authority decided to apply a precautionary measure in reducing the shelf life of Ifosfamide EG® at 7 months. One-year study from spontaneous reports lead to suspect a potential residual risk. Due to the many limitations associated with spontaneous notifications, we performed a multicentric observational study, aiming to better explore this pharmacovigilance signal.METHODS:We performed a case-control study in pediatric oncology Departments of 25 university hospitals between July 1st, 2016 and...
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