Benefit-risk review of Multaq started
Further to the report of two cases of serious liver injury in patients taking the anti-arrhythmic medicine Multaq (dronedarone), the European Commission has requested that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) assess all available data concerning the possible risks of liver injury associated with the use of Multaq and their impact on its benefit-risk balance.
The Committee discussed Multaq during its January 2011 meeting and concluded that there was a need for urgent regulatory action to help manage the possible risk of severe liver complications with the medicine.
The Committee recommended that warnings and precautions be introduced into the medicine’s prescribing information, to ensure that patients’ liver function is tested before initiation of treatment and closely monitored during treatment, and that treatment is stopped if there are signs of potential liver damage.
The review is being carried out as part of an ‘Article 20’ procedure. Its outcome will be made public once the CHMP has reached its final opinion.
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- EPAR: Multaq
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011 (21/01/2011)
Monika Benstetter or
Tel. +44 (0)20 7418 8427