Sanofi's Multaq Under Safety Review

The European Medicines Agency (EMA) has initiated a safety review of Sanofi’s anti-arrhythmic medicine Multaq following reports of serious liver injury in patients. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now assess all available data and their impact on the medicine’s benefit–risk profile.

There have been several reports of severe liver complications that could possibly be linked to Multaq, including two cases of liver failure requiring transplant. The CHMP did note that the two patients were also taking other medications; however, a causal relationship with Multaq has not been excluded.

As a precaution, the CHMP has also recommended that warnings and precautions be added to the medicine’s prescribing information to help manage the possible risk of severe liver complications. The CHMP believes that patients’ liver function should be tested before initiation of treatment and closely monitored during treatment for signs of potential liver damage.

Sanofi-aventis will also be providing a letter to healthcare professionals explaining the recommendations for use.

Multaq was authorized for use in the EU in November 2009 and is marketed in 16 member states, as well as Norway, for use in adults who have had atrial fibrillation in the past or who currently have non-permanent fibrillation. Multaq is used to prevent the fibrillation coming back or to lower the heart rate and contains the anti-arrhythmic active substance dronedarone.

In the US, Multaq was approved in July 2009, but the FDA placed the drug on a list of medications raising potential safety concerns in 2010. Earlier this month, the agency issued a drug safety communication about Multaq’s potential risk for severe liver injury.

www.ema.europa.eu