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Takeda’s Diabetes Drug Tied to Cancer Risk, U.S. FDA Says

June 16, 2011

(Updates with closing share price in fifth paragraph.)

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.

Takeda said it is working with the FDA to make “appropriate updates” to the drug’s prescribing information. The company is “confident in the therapeutic benefits of Actos and its importance as a treatment for Type 2 diabetes,” Takeda said in a statement.

Takeda shares fell 1.9 percent to 3,640 yen in Tokyo trading today, while the benchmark Topix Index lost 1.5 percent.

Initial Findings

The FDA announcement updated preliminary findings released nine months ago. The agency had said Sept. 17 that while it hadn’t found a statistically significant link between Actos and bladder cancer, the risk appeared to be higher in patients who took the drug for the longest duration, and at the highest cumulative doses.

The median duration of therapy was two years for patients treated with Actos, according to the FDA announcement. Treatment times ranged from 2.4 months to 8.5 years.

Doctors shouldn’t prescribe Actos to patients with active bladder cancer, the agency said. In patients with a history of bladder cancer, the drug’s benefits in controlling blood sugar levels “should be weighed against the unknown risks for cancer recurrence,” the FDA said.

Regulators in France said last week that the therapy will be withdrawn from the French market after a study they ordered showed a slight increase in the risk of bladder cancer.

Actos generated 384 billion yen ($4.1 billion) in sales in the fiscal year ended in March, Takeda reported.

--With assistance from Kanoko Matsuyama in Tokyo. Editors: Terje Langeland, Dave McCombs

To contact the reporter on this story: Molly Peterson in Washington at

To contact the editor responsible for this story: Reg Gale at

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