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European Medicines Aagency- PRAC update on use of ponatinib -Iclusig
08/11/2013
PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig
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.
read full press release here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2...