A DRUG used during the treatment of child and teenage cancer patients has been banned because of a link to increased secondary tumours.
The drug is normally used to protect the heart during cancer treatment but has now been banned from use for those under 18 because of "evidence of serious harm in children".
Cardioxane, made by Novartis, is now restricted to adult patients with advanced breast cancer.
Novartis has advised health care professionals not to use the drug for children and adolescents because of side effects.
They include "an increased risk of second primary malignances", severe suppression of the bone marrow's ability to produce blood cells and severe infection.
The company says that two studies reported a threefold increase in the incidence of secondary cancer tumours in children.
The suppression of the bone marrow and severe infection was also reported in one of the studies.
"In view of the evidence of harm and lack of data on clinical efficacy, the benefit:risk balance in children and adolescents is considered to be unfavourable," says Novartis in a safety communication.
It further advises that in adult patients with severe kidney dysfunction, the dose should be reduced by 50pc.
The company says safety issues have also been found in adult patients with advanced breast cancer.
Four cases developed leukaemia after treatment in combination with chemotherapy and there was also evidence of bone marrow suppression.
"In addition, in some studies, a higher incidence of death has been observed" in groups treated with both the drug and chemotherapy, compared with those who were just treated with chemotherapy alone.
It says the possibility that the drug "was a contributing factor to the imbalance cannot be ruled out".
Health care professionals have been advised to report any suspected adverse reactions associated with the use of Cardioxane to Novartis or to the Irish Medicines Board.