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Direct Healthcare Professional Communication (DHPC) on Xalkori® (Crizotinib): Visual disturbances, including risk of vision loss, need for monitoring in pediatric patients

Active substance: Crizotinib

Pfizer, in coordination with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), informs that visual disturbances are a known risk of crizotinib. Visual disturbances were reported in 61% of pediatric patients with tumors of the lymphoid tissue or soft tissues treated with crizotinib in clinical trials. Pediatric patients should be evaluated for visual disturbances.

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