Blood clot risk means additional monitoring needed with patients taking ponatinib
Healthcare professionals should apply more caution to the use of ponatinib (Iclusig) and carry out additional monitoring of patients receiving the anticancer drug, due to an increased risk of blood clots.
The recommendations have been made by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee following new information suggesting that the frequency of vascular occlusion events is higher than was observed when the medicine was approved in the EU in July 2013. The committee has also recommended that an in-depth review be carried out of the medicine’s benefit-risk ratio.
Moves to update product information were started on 24 October 2013 and the advice of the PRAC will now be considered by the Committee for Medicinal Products for Human Use (CHMP). An opinion is expected from the CHMP between 18 and 21 November.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11130250
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