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Takeda Responds to U.S. Food and Drug Administration Update to Safety Review of ACTOS (pioglitazone HCl)
Date:6/15/2011

DEERFIELD, Ill., June 15, 2011 /PRNewswire/ -- Following an announcement today from the U.S. Food and Drug Administration (FDA) regarding an update to its safety review of ACTOS, Takeda Pharmaceuticals North America, Inc. (Takeda) is confident in the therapeutic benefits of ACTOS and its importance as a treatment for type 2 diabetes. The company remains committed to ACTOS and ACTOS-containing medications, and to the millions of people living with the disease.

Takeda is dedicated to patient safety, and to ensuring that patients and physicians have accurate information regarding ACTOS. Takeda is committed to ongoing clinical research to understand and investigate potential safety concerns, and, working with appropriate regulatory agencies, is currently supporting a ten-year epidemiological study, started in 2002 by the University of Pennsylvania (U. of Penn.) and Kaiser Permanente Diabetes Registry, Northern California (KPNC), investigating the questions raised about ACTOS and bladder cancer. Takeda has been working with the FDA and European Medicines Agency (EMA) and has provided them with interim data from this study on a regular basis. Takeda is committed to supporting this study through its conclusion at the end of 2012 and will report on the final results upon completion.  

In the interim analysis of this epidemiologic data, published in Diabetes Care April 2011, the primary endpoint showed that treatment with ACTOS was not associated with a statistically significant increase in the incidence of bladder cancer. The investigators reported that "short-term use of pioglitazone was not associated with an increased incidence of bladder cancer, but use for more than two years was weakly associated with increased risk."  

Based on its recent data review, FDA has informed the public that "...use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer." 
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SOURCE Takeda Pharmaceuticals North America, Inc.
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