In a recent press release, EMEA made clear the new contraindications for the selective modulator (SERM) toremifene (Fareston):
Completing the review of the available data during its 19-22 January 2009 meeting, the CHMP concluded that the benefits of Fareston are greater than its risks, but that its use should be restricted.
The CHMP recommended that Fareston should no longer be used in patients with:
- prolonged QT intervals;
- electrolyte disturbances, particularly hypokalaemia (low blood potassium levels);
- clinically relevant bradycardia (abnormally slow heart rate);
- clinically relevant heart failure with reduced left-ventricular ejection fraction (inability of the heart to pump enough blood to the rest of the body);
- a history of symptomatic arrhythmias (abnormal heart rhythm).
In addition, the CHMP also recommended that Fareston should not be used together with other medicines that prolong the QT interval.
Source: Press Release – European Medicines Agency recommends new contraindication for Fareston (toremifene). PDF full text