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FDA Warning: Actos May Cause Bladder Cancer

June 15, 2011 – The U.S. Food & Drug Administration (FDA) has required that new information about an increased risk of bladder cancer be added to the Warnings and Precautions section of Actos (generic: pioglitazone) labels. The enhanced warning was prompted after the administration’s interim review of a study that found an increased risk of bladder cancer in patients taking the diabetes medication at a high dose for an extended period of time.

Actos Bladder Cancer Lawsuit Update April 8, 2014: In the first U.S. trial of its kind, Takeda Pharmaceuticals and Eli Lilly were ordered to pay a total of $9 billion in punitive damages after a jury agreed that the companies failed to warn the public and medical communities about the bladder cancer risk associated with their controversial type 2 diabetes drug Actos (pioglitazone). The lawsuit claimed that Takeda and Lilly downplayed or ignored concerns about Actos’ link to bladder cancer, and mislead health authorities in order to protect profits. Click here to learn more.

Free Actos Case Evaluation: If you or a loved one has been injured by Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

The new Actos safety information is based on the FDA’s five-year interim analysis of a ten-year epidemiological study that showed an increased risk of bladder cancer in patients with the longest exposure to Actos, and in those exposed to the highest cumulative dose of the drug. In response to the study, the FDA is recommending that physicians should not use Actos in patients with active bladder cancer or in patients with a prior history of bladder cancer. Doctors and patients are strongly advised to weigh the benefits vs. risks of Actos prior to beginning a regiment.

The FDA has also become aware of a recent Actos bladder cancer study conducted in France which suggests an increased risk of the disease with pioglitazone. Based on the conclusions drawn from the new information, France has banned Actos and Germany is advising doctors not to start Actos in new patients.

FDA is in the process of evaluating data from the ongoing ten-year study, and plans to conduct a comprehensive review of the European research. The administration will continue to update the public as more information becomes available.

What is Actos?

Actos is an FDA-approved oral prescription medication designed to control blood sugar levels in patients with type-2 diabetes. It is from the same class of drugs as Avandia (rosiglitazone), which has recently been linked to an increased risk of heart attacks and heart-related death. Serious Actos side effects may include:

  • congestive heart failure (CHF)
  • heart attack
  • stroke
  • liver problems
  • bladder cancer
  • fractures

The association between Actos and these side effects is so great that the FDA in 2007 enhanced the Warnings and Precautions label of the drug to include information about Actos congestive heart failure. The information was to be included in the form of a “boxed” warning – the strongest allowed by law. The upgraded warning emphasizes that Actos may cause or worsen heart failure in certain patients. Signs and symptoms of Actos-induced congestive heart failure may include:

  • rapid weight gain;
  • shortness of breath;
  • accumulation of fluid beneath the skin (edema) after starting drug therapy;
  • rapid or irregular heartbeat;
  • reduced ability to exercise;
  • persistent cough or wheezing with white or pink blood-tinged phlegm;
  • swelling of the abdomen (ascites);
  • sudden weight gain from fluid retention;
  • lack of appetite and nausea;
  • difficulty concentrating or decreased alertness.

Individuals injured by Actos may file a defective drug claim seeking compensatory damages to offset the cost of medical bills, lost income, lost opportunities and pain and suffering. Treating heart and bladder diseases can require extensive medical care and ongoing treatment, which can interfere with a person’s career and social life.

Do I have an Actos Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. We are handling individual litigation nationwide and currently accepting new bladder cancer cases in all 50 states.

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