UPDATE 4-Sanofi, Takeda drugs on FDA early safety probe list

Mon Jan 31, 2011 7:47pm 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 Takeda 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:
 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."
 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.
 Takeda's diabetes drug Actos also is under FDA review for
rhabdomyolysis, a potentially serious type of muscle injury.
 The company said it was aware of 67 reports of
rhabdomyolysis among about 15 million Actos patients. Most were
reported in Japan, "where the condition is more broadly
defined" than in the United States or Europe, Takeda
spokeswoman Elissa Johnsen said.
 "We will work closely with the FDA to better understand the
risk of rhabdomyolysis in patients treated with Actos," Johnsen
 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."
 (Reporting by Lisa Richwine; Editing by Gerald E. McCormick,
Tim Dobbyn and Sofina Mirza-Reid)

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.