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Shezad Malik MD JD
Shezad Malik MD JD
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Takeda’s Actos Diabetes Drug Increased Risk of Cancer

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According to an ongoing Actos product liability trial, in Los Angeles, the jury was told that Takeda Pharmaceutical Co., hid the cancer risks of its Actos drug to protect billions in sales. The plaintiff Jack Cooper has alleged that Takeda’s internal Actos studies demonstrated links to bladder cancer in 2004, and that the company didn’t notify the FDA until 2011.


According to Cooper's attorney, Mike Miller,“Selling diabetes drugs is big business in America. There’s a lot of money to be made. But companies are not allowed to downplay the risk. Patient safety is the No. 1 thing.”

Jurors will begin deliberating this week, on whether Takeda should be held liable for failing to properly warn patients and their doctors that Actos could cause bladder cancer. Sales of Actos peaked in the year ended March 2011 at $4.5 billion for Takeda and accounted for 27 percent of the company’s revenue at the time, according to data compiled by Bloomberg.

3,000 Actos Lawsuits and Growing

Takeda is facing more than 3,000 product liability lawsuits alleging Actos caused bladder cancer to diabetic patients, and Cooper’s suit is the first bladder cancer case to go to trial, and the outcome will be closely watched.

More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges or multidistrict litigation. The first federal case is set for trial in January 2014, according to court filings.

Actos and Bladder Cancer

During the almost two-month trial, Miller produced internal Takeda e-mails in which executives urged their colleagues to persuade the FDA not to demand increased warnings about bladder cancer on Actos’s label.

According to Miller, FDA officials asked the drugmaker in 2005 and 2006 to update warnings about Actos’ health risks, Takeda executives “stalled and delayed, that’s because the company was making $1.6 billion a year on the drug."

In August 2011, the U.S. Food and Drug Administration (FDA) informed the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. FDA previously communicated these labeling changes to the public on June 15, 2011 (Drug Safety Communication).

The updated drug labels recommend that healthcare professionals should:

  • Not use pioglitazone in patients with active bladder cancer.
  • Use pioglitazone with caution in patients with a prior history of bladder cancer.

The updated drug labels recommend that patients should:

Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.

The case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles).