Further review of Iclusig started
The European Medicines Agency has started an in-depth review of the benefits and risks of the leukaemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine.
In November 2013, the European Medicines Agency reviewed updated clinical trial data with Iclusig indicating that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine’s initial authorisation. The Agency therefore recommended a number of measures to help minimise this risk. These included a warning against use in patients who have had a heart attack or stroke in the past, and a recommendation that the cardiovascular risks (affecting the heart and blood vessels) of all patients be assessed and measures be taken to reduce such risks before and during treatment with Iclusig. Treatment with Iclusig should be stopped immediately in any patient with signs of a blockage in the arteries or veins.
However, a number of issues required further investigation, including a better understanding of the nature, frequency and severity of events obstructing the arteries or veins, the potential mechanism through which the medicine leads to these side effects and whether there is a need to revise the dosing recommendation of Iclusig. Therefore, the European Commission considered that a further in-depth review of relevant data was necessary.
The Agency will now carry out this review to assess the need for further changes to how the medicine is used.
Most read news
Other news from the department politics & laws

Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.
Most read news
More news from our other portals
Last viewed contents
Posaconazole
Category:Glycoproteins

Ageing the unageable - Researchers develop new way to age lobsters
Apceth and Indivumed to Develop Biomarker Platform for Targeted Cellular Therapies
International_Society_for_Pharmaceutical_Engineering
Respiratory_acidosis
Edmund_O'Meara
Kaempferol
