The CHMP reviewed Fareston due to concerns over its cardiovascular effects, in particular the concern that it could cause prolongation of the QT interval.
The Committee concluded that the benefits of toremifene outweigh its risks for the treatment of hormone-dependent metastatic postmenopausal breast cancer, but that its use should be resricted.
Toremifene should no longer be used in patients with prolonged QT intervals, electrolyte disturbances, clinically relevant bradycardia, heart failure with reduced left-ventricular ejection fraction or a history of symptomatic arrhythmias. In addition, it should not be used with other medicines that prolong the QT interval.
Further information: EMEA Q&A on Fareston review