Changes have been made to the warnings, side effects and overdosage sections of the data sheet for Wyeth's Novantrone (mitozantrone 2mg/ml) injection, following a safety review of the product. The warnings section has been extended to include a paragraph on the use of Novantrone during breastfeeding. The following statement has been added to the side effects section: "Topoisomerase II inhibitors, including Novantrone, in combination with other antineoplastic agents, have been associated with the development of acute leukaemia." The addition made to the overdosage section refers to fatalities that have occurred in patients who have accidently been given single bolus injections of mitozantrone at over 10 times the recommended dosage.