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Takeda Failed to Warn of Actos Cancer Risk Lawsuit Alleges

Filed March 5th, 2013 admin

A lawsuit filed against Takeda Pharmaceutical alleges that the drug maker failed to warn doctors of the cancer risk associated with its Type II diabetes drug, Actos.

The lawsuit, filed by Jack Cooper, claims that Takeda never warned doctors that the drug could lead to bladder cancer. Cooper took the medication for more than four years and was diagnosed with bladder cancer in 2011, Bloomberg.com said. Actos was approved by the U.S. Food and Drug Administration (FDA) in 1999 and quickly became the world’s top-selling diabetes drug. Takeda has faced mounting criticism in recent years after studies have linked Actos to increased cancer risks. Regulators in France and Germany forced Takeda to pull Actos off the markets in those countries, Bloomberg.com said.

Cooper’s lawsuit alleges that Takeda researchers ignored or downplayed concerns over the drug’s cancer risks prior to it being placed on the U.S. market in 1999 and misled the FDA about Actos’ risks, said Bloomberg.com.

Takeda’s sales representatives visited Cooper’s family doctor every two weeks over an eight-year period beginning in 1999, Bloomberg.com said, citing the lawsuit. Despite nearly 200 visits, Takeda’s sales reps failed to mention the drug’s increased cancer risk to Cooper’s doctor until August 2011, Bloomberg.com said. Cooper’s doctor stopped writing new Actos prescriptions that month and barred Takeda’s sales people from his office.

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