Actos Bladder Cancer Link Alleged in Lawsuit

If the diabetes does not kill you, the bladder cancer might. That’s the gist of a lawsuit, filed April 25 in the Louisiana Western District Court, in which plaintiff Donald Shingleton alleges he suffers from bladder cancer after taking Actos for se

veral years.

Actos is a drug used to control type 2 diabetes. It has been a blockbuster for its maker, Japan-based Takeda which last year logged $4.5 billion in Actos sales.

Diabetes is an ever more common disease in the United States. The American Diabetes Association estimates that nearly 26 million of us – almost 10 percent of the population – suffers from diabetes, a disease characterized by the body’s inability to manufacture or to efficiently use insulin. It is linked to cardiovascular disease, kidney failure and blindness.

Actos bladder cancer lawsuits given MDL treatment in federal court

Shingleton is not alone in claiming an Actos bladder cancer connection. So many Actos bladder cancer cases have been filed, or are expected to, that US Judge Rebecca Doherty now oversees the so-called Multi District Litigation (MDL) for Actos related cases. “This court has been informed by counsel that the number of claims which will be included could reach into the thousands,” Doherty wrote in a recent order naming special masters to help manage the legal traffic jam.

Since the case was assigned MDL status in December, over 200 cases from courts around the nation have been transferred into the Louisiana district

Singleton, in his Actos bladder cancer lawsuit, said he had taken Actos for “many years” and as a result he suffered “life-threatening injuries.” The many other suits are said to make essentially the same allegation.

The FDA, meantime, in June, 2011 issued a Drug Safety Communication that explicitly warns against taking Actos for more than a year because the drug “may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”

The FDA warning continued: “FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone [aka Actos]. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.”

The FDA warned patients with active bladder cancer not to take Actos.

The FDA advisory did not warn patients with no history of bladder cancer away from Actos.

It added this patient advice for those taking Actos:

“Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain

while urinating; pain in back or lower abdomen.”

A complication is that a drug that had been touted as the successor to Actos – alogliptin, also from Takeda – was turned down by the Food and Drug Administration in late April. The FDA requested more information in the use of the drug outside the US.

This is the second time the FDA has turned down alogliptin. In 2009 it also requested more information.


is scheduled to lose patent protection in the US in late summer.

Two separate studies by Canadian researchers published in May and July 2012 both found evidence supporting the Actos bladder cancer link. The May study found that using Actos for two years doubled a patient’s risk of developing Actos bladder cancer.


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