Modification of product information under way to include strengthened
warnings
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), at its 4-7
November meeting, reviewed new information on the cancer medicine Iclusig (ponatinib) that suggests
that side effects such as vascular occlusive events (blood clots obstructing the arteries or veins) occur
at a higher rate than initially observed at the time of granting the European Union (EU) marketing
authorisation in July 2013.
Conditions related to thrombosis such as myocardial infarction (heart attack) are known side effects of
Iclusig and the current EU product information mentions the risk of myocardial infarction, cerebral
infarction (stroke) and related disorders.
The PRAC advice is that patients and healthcare professionals may continue to use this medicine with
increased caution in its authorised use and should monitor carefully for evidence of thromboembolism
(formation of blood clots in the veins and arteries) and vascular occlusion.
Iclusig is an anticancer medicine belonging to the class of tyrosine kinase inhibitors, used to treat
patients with chronic myeloid leukaemia and Philadelphia-chromosome positive acute lymphoblastic
leukaemia. In the EU, since the initial approval, the medicine's use had been limited to patients who
had no other available treatment options with medicines of this class, for example because they were
intolerant to other medicines of this class or their disease was resistant to such treatment.
The PRAC has advised that the product information should be updated to include strengthened
warnings on the cardiovascular risk and guidance on optimising the patient's cardiovascular therapy
before starting treatment. This advice will now be considered by the Agency's Committee for Medicinal
Products for Human Use (CHMP), in the context of an ongoing procedure started on 24 October 2013
to update the product information of this medicine. The CHMP is expected to issue an opinion during its
next meeting, which will take place from 18 to 21 November.
In addition to changes in the product information, the PR
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