European Medicines Agency Warning on Risk of Arterial Thrombosis with Ponatinib
Highlights from the October 2013 meeting of the Committee for Medicinal Products for Human Use
- Date: 28 Oct 2013
- Topic: Anticancer agents & Biologic therapy
As a result of the meeting of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP), 21-24 October 2013, the CHMP has declared that a review of product information is underway for ponatinib (Iclusig). Following the emergence of new data on the risk of arterial thrombosis with ponatinib, the CHMP concluded that the product information for prescribers and patients should be reviewed and amended if appropriate to include information and warnings about this risk. A formal procedure is currently underway to implement this update.