Further review of Iclusig started
The European Medicines Agency has started an in-depth review of the benefits and risks of the leukaemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine.
In November 2013, the European Medicines Agency reviewed updated clinical trial data with Iclusig indicating that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine’s initial authorisation. The Agency therefore recommended a number of measures to help minimise this risk. These included a warning against use in patients who have had a heart attack or stroke in the past, and a recommendation that the cardiovascular risks (affecting the heart and blood vessels) of all patients be assessed and measures be taken to reduce such risks before and during treatment with Iclusig. Treatment with Iclusig should be stopped immediately in any patient with signs of a blockage in the arteries or veins.
However, a number of issues required further investigation, including a better understanding of the nature, frequency and severity of events obstructing the arteries or veins, the potential mechanism through which the medicine leads to these side effects and whether there is a need to revise the dosing recommendation of Iclusig. Therefore, the European Commission considered that a further in-depth review of relevant data was necessary.
The Agency will now carry out this review to assess the need for further changes to how the medicine is used.
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