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A diabetes drug called Actos (pioglitazone) has been found to double the risk of bladder cancer in patients using the drug for over two years.

Actos is of a class of drugs called thiazolidinediones that are used to treat patients with diabetes mellitus (Type 2 diabetes). Actos works by decreasing the body’s resistance to insulin, which helps control blood sugar levels. It is taken in pill form once a day without food.Although the drug already carries a bladder cancer risk warning, this new research indicates that the danger is much greater than previously believed.

The risk of developing bladder cancer is still quite small. But researchers urge that those patients with a history of bladder cancer or other bladder ailments should not use the medicine.The research found that people who had taken Actos had an 83% increased risk of cancer of the bladder, with the risk increasing after two years and at significantly higher doses of the drug.Avandia (rosiglitazone), another diabetes drug in this class, was not found to have a link to bladder cancer.

Takeda Pharmaceuticals, the manufacturer of Actos, said it has not reviewed the study but reaffirmed its belief in the therapeutic value of the drug, and maintained that Actos has a positive risk profile.Dr. Spyros Mezitis of Lennox Hill Hospital in New York City said that doctors should use urine samples to determine whether or not patients have or have had bladder cancer before prescribing Actos.

The Actos label warns that those who are receiving treatment for bladder cancer should not take it. Also, the drug has already been banned in France and Germany.There are other, unrelated risks associated with use of Actos, including strokes, congestive heart failure, macular edema, blindness, increased risk of liver failure, as well as hepatitis, extreme weight gain and increased risk of fractures.

Billions Awarded in Lawsuit Over Actos Risks

About a year ago, on April 8, 2014, Bloomberg reported that Takeda and Eli Lilly & Co. were ordered to pay $9 billion in punitive damages among the two companies after a federal jury found that the companies had hid the risks of cancer found in the first trial study of its kind.

The jury, in Lafayette, Louisiana, ordered the Osaka, Japan-based Takeda to pay $6 billion, with Eli Lilly, the Japanese company’s US-based partner, ordered to pay $3 billion. Former Actos user Terrence Allen was awarded $1.5 million in compensatory damages.

Because evidence in the trial indicated that Takeda agreed to indemnify Lilly for all legal liability related to Actos, it is likely that, after appeals and any adjustments to the verdict, Takeda will be on the hook for the entire judgment.

Takeda Had Misled Regulators

In the lawsuit, Allen alleged that pharmaceutical executives ignored or downplayed concerns about the drug’s cancer risks and misled regulators in order to protect its potential billions in sales. In addition, Takeda destroyed thousands of documents relating to Actos trials, leading jurors to assume that the company was hiding something disconcerting. These concerns contributed to the size of the verdict, one of the biggest in American history.

“This verdict sends a message that you must put the health and safety of Americans ahead of profits, or American juries will have the courage and resolve to hold global corporations accountable,” said Neil Overholtz, a Florida lawyer who represents former Actos users.


A big lesson for consumers from this debacle is that the Food and Drug Administration (FDA) can still approve a drug even if it has undisclosed side effects.