Quoted from http://www.businessweek.com/news/2011-06-16/takeda-s-diabetes-drug-tied-to-cancer-risk-u-s-fda-says.html
Takeda’s Diabetes Drug Tied to Cancer Risk, U.S. FDA Says
June 16, 2011, 2:41 AM EDTBy Molly Peterson
June 16 (Bloomberg) -- Takeda Pharmaceutical Co.’s diabetes drug Actos may raise bladder cancer risks in patients who take the medicine for more than a year, U.S. regulators said.
A five-year interim analysis of data from a decade-long company-sponsored study showed a greater likelihood of bladder cancer in patients who took the drug for the longest periods of time, and at the highest cumulative doses, the Food and Drug Administration said in a safety announcement yesterday. The medicine from Osaka, Japan-based Takeda, Asia’s biggest drugmaker, wasn’t linked to an overall increased cancer risk in all patients who took it.
Actos, the world’s biggest-selling diabetes drug, had shown a potential risk of bladder cancer in earlier studies on rats and humans. Takeda won FDA approval of the treatment in 1999 and agreed to conduct the 10-year study to assess that risk. Actos became the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from London-based GlaxoSmithKline Plc’s Avandia.
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