A June 14, 2022, European Pharmaceutical Review (EPR) article about the most recent meeting of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reports a new drug safety issue involving Xalkori-related vision disorders found in clinical trials for pediatric patients treated with Xalkori.
In relevant part from this EPR article about the EMA’s PRAC June meeting highlights:
Xalkori has been studied in children from six to 18 years of age as a monotherapy for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK positive or patients with unresectable, recurrent, or refractory ALK positive inflammatory myofibroblastic tumour (IMT).
Vision disorders have been reported in 61 percent of paediatric patients treated with [Xalkori (crizotinib)] in clinical trials for these indications.
We point out there were some revisions made in January 2021 to the “5.5 Severe Visual Loss” part of the WARNINGS AND PRECAUTIONS section in the Xalkori Prescribing Information document, but this pertained to patients generally, not pediatric patients only.
To date, however, we have not seen any similar FDA warning about this new drug safety issue involving Xalkori-related vision disorders for children.
We will continue to monitor the drug regulatory sector as well as the medical literature for further developments concerning ocular toxicity and severe visual loss in children treated with Xalkori.[Read article in full at original source]
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