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The European Medicines Agency’s (EMA) Committee on Medicinal Products for Human Use (CHMP) met on Friday to discuss the ongoing benefit-risk review of the anti-arrhythmic medicine, Multaq (dronedarone).
All available data on the risk of cardiovascular problems, liver and lung injuries reported with the use of Multaq were discussed in order to prepare for the Committee’s next scheduled meeting of 19-22 September 2011, when it expects to finalise its review.
The review of Multaq began in January on the request of the European Commission, following reports of liver damage in two patients taking the medicine.
In July, the scope of the review was extended to also look at new data related to the effects of the medicine on the heart, blood vessels and lungs.
The Committee held its latest meeting outside of its normal schedule because the new information on the safety of Multaq only became available shortly before the Committee’s last plenary meeting of 18-21 July 2011.
The assessors analysed the new data in depth, as well as additional information requested from the marketing-authorisation holder, in preparation for Friday’s meeting.
Multaq has been authorised in the European Union since November 2009 for use in patients with atrial fibrillation.
The Agency will announce the outcome of the Committee’s discussions and explain the next steps following its final review of September 19-22.
