UPDATE 3-Sanofi, Takeda drugs on FDA early safety probe list

Mon Jan 31, 2011 5:14pm EST

* FDA probing Sanofi heart drug, Takeda diabetes pill

* List does not mean drug causes problem, FDA says

* Sanofi says confident in safety profile of Multaq (Adds Sanofi comment)

WASHINGTON, Jan 31 (Reuters) - U.S. regulators have launched early investigations into potential risks of drugs from Sanofi-Aventis (SASY.PA), Takeda Pharmaceutical Co (4502.T) and other companies, the Food and Drug Administration said on Monday.

The FDA released its quarterly list of investigations into possible drug-safety problems. The newest list covers probes launched between July and September 2010.

Appearing on the list does not mean the FDA has concluded a drug causes the listed problem, the agency said. It also "does not mean that FDA is suggesting that healthcare providers should not prescribe the drug or that patients taking the drug should stop taking the medication."

The list was posted on the FDA's website at: bit.ly/eKC2cp

Among the probes, the agency is reviewing a possible interaction between Sanofi's heart drug Multaq and the bloodthinner warfarin that could lead to an "increased anticoagulant effect."

Takeda's diabetes drug Actos is under review for rhabdomyolysis, a potentially serious type of muscle injury.

The FDA provided little detail on the cases. For most of the drugs, the agency said it was "continuing to evaluate this issue to determine the need for regulatory action."

Sanofi said in a statement it was "confident in the overall safety profile of Multaq," a drug used to treat abnormal heart rhythms called atrial fibrillation or atrial flutter.

"It is important to note that the FDA has not identified a causal relationship between Multaq use" and clotting time in patients taking warfarin, the company said.

A Takeda spokeswoman had no immediate comment. (Reporting by Lisa Richwine; Editing by Gerald E. McCormick and Tim Dobbyn)

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