Brand Name(s):Xagrid, Agrelin
Indication:Polycythaemia vera, Thrombocytosis,
Communication on the association of anagrelide hydrochloride (Xagrid 0.5mg hard capsules) with cardiovascular risk in patients with essential thrombocythaemia (ET), whatever the patient’s medical history or medical condition, and a reminder that the indication for anagrelide is second line therapy in at risk essential thrombocythaemia patients.
Serious cardiovascular adverse events may occur in patients without any suspected heart disease and with normal previous cardiovascular investigations.
The addition of this statement to the Xagrid SmPC does not alter the current
benefit/risk of anagrelide in the context of its therapeutic indication as a second
line treatment in at risk essential thrombocythaemia (ET) patients.
The communication of this information has been agreed with the European
Medicines Agency and the Medicines and Healthcare Products Regulatory
23 January 2013
Further information available at: http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con228796.pdf