Actos bladder cancer lawsuit

Actos Bladder Cancer Lawsuit and FDA Warning

The Actos bladder cancer lawsuit is in response to studies shown that Actos users face an increased risk of developing bladder cancer, and the U.S. Food and Drug Administration (FDA) has issued an Actos bladder-cancer warning. Actos® (pioglitazone) is a medication manufactured by Takeda Pharmaceuticals which is prescribed to control glucose (blood sugar) in adults with Type 2 diabetes.

It is sold under the brand name Actos, as well as ACTOplus Met®, Duetact®, and the generic name, Metformin or Pioglitazone.

What you need to know about the Actos Bladder Cancer Lawsuit

In June 2011, the Food and Drug Administration (FDA) issued a Safety Announcement regarding Actos and related medications due to the risk of bladder cancer associated with using these medications. The FDA’s Announcement was based on their review of data from a planned five-year interim analysis of an ongoing ten year study. Preliminary results from the study showed a 40 percent increase in the risk for bladder cancer in patients taking Actos for more than one year.

As a result of these findings, the FDA advised Actos users that there may be an increased likelihood of developing bladder cancer in connection with use of Actos/pioglitazone. The FDA has advised Actos users to tell their doctor right away if they have any of the following symptoms of bladder cancer:

  • Blood in the urine
  • Discolored urine
  • An urgent need to urinate
  • Painful urination
  • Frequent urination
  • Pain in the lower back or abdomen
  • Weight loss

Research shows a link between taking Actos and developing bladder cancer, the FDA has approved changing the pioglitazone label to state that pioglitazone should not be prescribed to patients with bladder cancer and that the drug should be used with caution for those with a history of bladder cancer.

Did you Know? Actos Bladder Cancer Lawsuit Facts

Takeda, the drug manufacturer, has conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. There was no statistically significant association between Actos exposure and bladder cancer risks. Further analyses were also performed looking at how long patients were on Actos, and the total amount of the drug they received during that time. Increased risks of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics.

Bladder cancer can sometimes cause changes in urination, such as:

  • Having to urinate more often than usual
  • Pain or burning during urination
  • Feeling as if you need to go right away, even when the bladder is not full
  • Having trouble urinating or having a weak urine stream

These symptoms are also more likely to be caused by a urinary tract infection (UTI), bladder stones, an overactive bladder, or an enlarged prostate (in men). Still, it’s important to have them checked by a doctor so that the cause can be found and treated, if needed.

Additional Information for Patients using Actos

  • Do not stop taking your Actos unless told by your healthcare professional.
  • FDA has not concluded that Actos increases the risk of bladder cancer. The Agency is reviewing this safety concern and will update the public when additional information is available.
  • Talk to your healthcare professional if you have concerns.
  • Report side effects immediately from the use of Actos to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

How to get help with the Actos Bladder Cancer Lawsuit

Thousands of lawsuits across the nation have been filed against Takeda on behalf of individuals diagnosed with bladder cancer after ingesting Actos. These lawsuits allege that the drug maker failed to adequately warn patients about the potential risk of bladder cancer associated with Actos use. In April 2015, Takeda agreed to pay $2.4 billion to settle all bladder cancer claims brought against the company.