FDA strengthens warnings on Sanofi's Multaq; Aubagio disappoints

The US Food and Drug Administration (FDA) has completed a safety review of French drug major Sanofi’s (Euronext: SAN) heart drug Multaq (dronedarone), concluding that the drug increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).

This update is a follow-up to the FDA Drug Safety Communication on July 21, 2011, about Multaq and increased risk of death and serious cardiovascular events. Multaq already carries a black box warning, saying the drug can cause severe complications, including death, in people with recent severe heart failure and should not be used by them. Also, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that, due to an increased risk of liver, lung and cardiovascular adverse events, the use of Multaq should be restricted to patients with paroxysmal or persistent AF (The Pharma Letter September 23).

First approved in 2009, Multaq – once touted as having blockbuster potential - generated sales of $224 million in 2010 and 66 million euros (around $86 million) in the third quarter of this year, a year-on-year rise of 52%, despite the side effect warnings.