Warnings about the risks of developing a blood clot or blocked artery with Iclusig (ponatinib), a leukaemia treatment, are to be made more robust, following the results of a European Medicines Agency (EMA) review.
The EMA says that any risks are likely to be linked to dosage but insufficient data means that it does not have enough information to recommend that the existing starting dose of 45mg a day should change. The agency announced that it is launching a study into the safety and benefits of Iclusig, with a focus on dosage, to help clarify whether lowering the dose would also reduce the associated risks.
The regulator has advised doctors to stop prescribing Iclusig after three months if a complete haematological response has not occurred. Patients should also be monitored for high blood pressure or signs of heart problems, according to the EMA.
The drug’s UK manufacturer, Ariad Pharma Ltd, has promised to provide new educational material to health professionals about monitoring patients prescribed Iclusig and the recommended dose adjustments.