The agency is reviewing a possible interaction between Sanofi’s heart drug Multaq and the blood thinner Warfarin that could lead to an ‘increased anticoagulant effect’. Takeda’s diabetes drug Actos is also under the scanner for rhabdomyolysis.
In response, Sanofi has said that it was confident in the overall safety profile of Multaq, and that it is noteworthy that the FDA has not identified a causal relationship between Multaq use and clotting time in patients taking warfarin.
Meanwhile, Takeda spokeswoman Elissa Johnsen has said that the company would work closely with the FDA to better understand the risk of rhabdomyolysis in patients treated with Actos.