EMA Recommends Restricting the Use of Dexrazoxane-containing Medicines

Following review of all available data, the CHMP concluded there was evidence of serious harm in children and adolescents receiving dexrazoxane.

The European Medicines Agency has recommended restricting the use of dexrazoxane to adult patients with advanced or metastatic breast cancer who have already received a certain amount of the anthracyclines doxorubicin and epirubicin to treat their cancer.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) also recommended contraindicating the use of this medicine in children.

Dexrazoxane is currently indicated for use in patients with cancer to prevent long-term toxic effects on the heart caused by treatment with doxorubicin and epirubicin.

Following review of al