The European Medicines Agency’s Committee for Medicinal Products for Human Use (CMHP) recommended on September 23, 2011 that use of Multaq, an anti-arrhythmic medication manufactured and marketed by Sanofi-Aventis, be restricted.
The CMHP began evaluating data as a result of post-marketing reports of severe liver injuries among users of Multaq. The CMHP also reviewed potential cardiovascular injuries following the early termination of a clinical trial of Multaq in an off-label population. Ultimately, the CMHP determined that use of Multaq as approved increased the user’s risk of injury to the liver and the lungs.
As a result of the increased risk of liver and lung injury, the CMHP has recommended that Multaq be used only after other treatment options have been considered, and only in patients in whom atrial fibrillation is no longer present. Patients currently taking Multaq should discuss the CMHP’s recommendations with their physicians, and lung function, liver function, and heart rhythm should be monitored for patients on Multaq.
The recommendation of the CMHP has been forwarded to the European Commission, which will make a final decision.
Multaq was first approved for use in the United States by the FDA in July of 2009, and was indicated for treatment of atrial fibrillation or atrial flutter in certain patients. Based on safety signals related to liver injury received by the FDA in late 2010, the American agency required the Multaq label to change in February, 2011. The new label notes that use of Multaq should be stopped if liver injury is suspected.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.