We thank Dr Lipshultz for pointing out an error in our characterization of the European Medicines Agency action on the use of dexrazoxane as a cardioprotective agent for patients receiving… Click to show full abstract
We thank Dr Lipshultz for pointing out an error in our characterization of the European Medicines Agency action on the use of dexrazoxane as a cardioprotective agent for patients receiving anthracycline chemotherapy.1 One of the leaders in the field of pediatric cardio-oncology, Dr Lipshultz was responsible for many of the important studies, cited in our editorial, that characterized the greater than appreciated occurrence of doxorubicin cardiotoxicity in children. In his letter, Dr Lipshultz specifically raises issue with our notation that the European Medicines Agency had limited the indication for dexrazoxane to adult patients with advanced disease and contraindicated its use in children in Europe. Dr Lipshultz correctly points out that the European Medicines Agency recently modified this recommendation in July, 2017, such that dexrazoxane is no longer contraindicated in children at the greatest risk of cardiotoxicity (those who receive a cumulative dose of 300 mg/m2 of doxorubicin). In this regard, we stand corrected and would not want to discourage clinicians from considering the appropriate use of this important cardioprotective agent. However, we also note that the full text of the European Medicines Agency decision begins with the statement that “the benefits and risk of dexrazoxane have not been established in children under the age of 18 years…” and that dexrazoxane remains “contraindicated in patients under 18 years old who…receive a total cumulative dose of …
               
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