Actos and Bladder Cancer

Long-term use of Actos can cause bladder cancer and other health problems

Actos (pioglitazone) is a diabetes drug that increases users' tolerance to insulin and controls blood glucose. Pioglitazone is also an active ingredient in the medications Actoplus Met XR, Actoplus Met and Duetact.

Actos and a similar drug, Avandia, comprise a class of drugs called Thiazolidinediones, which are used to treat Type-2 diabetes. Both have been linked to life-threatening conditions that have triggered numerous lawsuits. If you believe you or a loved one has been harmed by Actos, contact a personal injury attorney to find out if you have grounds for an Actos lawsuit.

FDA Bladder Cancer Warnings

In June of 2011, the Food and Drug Administration (FDA) released an Actos bladder cancer warning. This came on the heels of an interim analysis of an epidemiological study conducted by the manufacturer of Actos: Takeda Pharmaceuticals. The study showed no increased risk of bladder cancer overall. However, long-term Actos users and Actos users with the highest cumulative dose of the drug did show an increased risk.

An Actos study conducted in France had similar findings, prompting a recall of the drug in that country and other precautionary measures in Germany and elsewhere. The FDA has said that it is aware of the French study and intends to review its findings. The agency will also continue to observe the Takeda Pharmaceuticals study.

The FDA is advising Actos users that taking the drug for longer than a year increases the user's risk of developing bladder cancer. However, patients should not discontinue use of Actos without first speaking to their physicians.

Doctors are advised to use caution when prescribing the drug to bladder cancer patients. Patients who have active bladder cancer should not take Actos. All of these recommendations will appear on the Warnings and Precautions portion of the Actos label and in the medication guide that comes with the drug.

Other suggestions for patients from the FDA include the following:

  • Schedule an appointment with your doctor if you experience pain in the lower abdomen or back; if you feel pain while urinating; if you feel the urgent need to urinate; if blood appears in your urine; or if your urine appears to be more red
  • Avoid Actos if you are receiving treatment for bladder cancer
  • Report side effects to the FDA MedWatch program
  • Talk to your doctor if you have questions
  • Review the medication guide you received with the Actos prescription; it contains comprehensive Actos information, including risks associated with Actos
  • Note that using Actos may increase your risk of developing bladder cancer

Additional Dangers Associated With Actos and Avandia (Thiazolidinediones)

Bladder cancer is not the only risk associated with thiazolidinediones. There have been reports of health problems caused by these drugs for years. In June of 2007, the FDA issued a "black box warning" due to reports of liver and heart problems among patients taking Actos and Avandia. This warning was the result of a Cleveland Clinic study, which found that thiazolidinediones may increase a patient's risk of having a heart attack by up to 42 percent. In addition, the study found that Actos and Avandia can increase the risk for a variety of liver problems, including liver inflammation, hepatitis, elevated liver enzymes (a sign of liver damage) and liver failure. Actos and Avandia can also increase the risk of bone fractures in women.

If you or a loved one has developed a dangerous health condition you believe may have been caused by taking Actos or Avandia, contact your doctor immediately. To learn about your legal rights, as well as bladder cancer and Actos, speak to a personal injury attorney who is familiar with the laws in your state.

Page Updated June 23, 2011

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