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FDA launches early probes on Sanofi, Takeda drugs

The US-based Food and Drug Administration has launched early investigations into potential risks of drugs from Sanofi-Aventis, Takeda Pharmaceutical and other companies after it released its quarterly list of investigations into possible drug-safety problems.

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.