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Takeda Concerned About Link Between Actos and Bladder Cancer, Per Filing

A New Court Filing Shows that Takeda Pharmaceuticals Knew About a Possible Link Between Actos and Bladder Cancer

According to a new court filing in the multidistrict litigation (MDL) against Takeda Pharmaceuticals, the company’s executives were concerned, as early as 2003, that there might be a link between their diabetes drug Actos and an increased risk of bladder cancer.

The FDA warns that taking Actos for more than one year is linked to an increased risk of bladder cancer
The FDA warns that taking Actos for more than one year is linked to an increased risk of bladder cancer

Executives began questioning doctors about whether or not they would prescribe the drug if Actos had a warning label regarding the potential danger to patients.

In 2003, Takeda secretly surveyed a dozen doctors on their opinion about warning labels attached to Actos. Their survey found that a strong warning label would destroy sales of this potentially lucrative drug.

However, in court, faced with 3,000 personal injury and wrongful death lawsuits, the Actos manufacturer has argued strongly that their drug does not cause bladder cancer. They argue that they took proper steps to inform doctors about all known side effects of Actos, and that they have always emphasized patient safety.

“Takeda has actively worked with regulators, physicians and outside medical experts to make sure health-care providers were informed and could make the most educated treatment decisions,” Kenneth D. Greisman, a spokesman for the company’s U.S. unit, said today in an e-mailed statement. “That was the case in 2003 and still is the case today.”

Plaintiff Jack Cooper’s lawyers argued that Takeda intentionally refused to search it’s database for signs of a link between Actos and bladder cancer, because it would provide ammunition for stronger warnings. Mr. Cooper’s case goes to trial on February 19th.

Attorneys for the plaintiff also allege that Takeda instructed its sales force to downplay the link between the drug and bladder cancer. According to one filing, Takeda told US salespeople to wait and see if doctors had specific questions about the link to bladder cancer, “if no questions/concerns, do not discuss bladder cancer and sell, sell, sell!”

Takeda alleges that Mr. Cooper’s lawyers are cherry-picking through documents to paint a misleading picture of the medical manufacturer.

Despite Years of Concerns, FDA Approves New Versions of Actos

Until the personal injury lawsuits and the recent patent expiration, Actos was Takeda’s top-selling drug. The manufacturer has produced other drugs to treat Type 2 diabetes which use pioglitazone, but until this past year, the FDA had not approved any of the other drugs for use in the United States. However, in January 2013, the FDA approved new versions of the drug produced by Takeda Pharmaceuticals for sale in the US, despite public outcry and more and more lawsuits joining the MDL.

Despite the FDA’s recent approval of generic and non-generic pioglitazone drugs, the government organization last summer issued the strongest possible warning label for Actos. On their website, the FDA warns that taking Actos for more than one year is linked to an increased risk of bladder cancer.

In 2011, after disturbing findings linking Actos to bladder cancer and some other diseases, both France and Germany banned the drug.

The Strom Law Firm Can Help with Personal Injury and Wrongful Death Cases, Including Against Actos

If you or a loved one have taken Actos to treat Type 2 diabetes, and have since suffered dangerous side effects including developing bladder cancer, heart disease, liver failure, or diabetic macular edema, you may be entitled to compensation. The attorneys at the Strom Law Firm can help with personal injury cases, including against Actos manufacturer Takeda Pharmaceuticals. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us. 803.252.4800



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