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Actos (pioglitazone) is one of the world’s widely prescribed diabetes medications. Also marketed in combination with glimepiride (Duetact) and metformin (Actoplus Met, Actoplus Met XR), Actos is used by millions of patients with Type-2 diabetes. The drug works by controlling blood glucose levels through its action with insulin.


Now, Actos has also been linked to life-threatening side effects. In June 2011, the Food and Drug Administration (FDA) issued a warning to alert patients and healthcare professionals of an increased risk of bladder cancer associated with Actos. This followed another FDA warning, issued in June 2007, with reports of liver damage and cardiovascular problems among patients taking Actos.

If you have been diagnosed with bladder cancer or another condition you feel may be linked to taking Actos, the FDA recommends that you schedule an appointment with your doctor immediately.

Bladder Cancer Risk and Actos Usage

The FDA issued its Actos bladder cancer warning after an interim analysis of a 10-year epidemiological study conducted by the drug’s manufacturer, Takeda Pharmaceuticals. The analysis showed no increased risk of bladder cancer among users as a whole. The longest-term users of Actos and those with the highest cumulative dose of the drug showed increased levels of bladder cancer.

A separate study of Actos, conducted in France, has also linked the drug to bladder cancer. The FDA is aware of these findings and has stated that it intends to conduct a thorough review of the study and its findings. The agency has also stated that it will continue monitoring data from Takeda’s ongoing study.

In the meantime, the FDA has advised patients that taking Actos for longer than a year puts them at risk. The FDA recommends that patients with active bladder cancer avoid taking Actos. Physicians should use caution when prescribing Actos to patients with a history of bladder cancer, weighing the benefits of the drug to the risk of recurrence.

The FDA has also provided the following tips for patients:

  • Taking Actos may increase your odds of developing bladder cancer
  • Go to a doctor if you notice that your urine is red in color or if you see blood; if you are experiencing an extreme urge to urinate or pain while doing so; or if you are experiencing pain in your lower abdomen or back
  • Do not take Actos if you are receiving bladder cancer treatment
    Report any side effects you notice to the FDA MedWatch program
  • Read the medication guide you get with your Actos prescription, which contains detailed information on risks associated with the drug
  • These warnings and recommendations will appear on the Warnings and Precautions section of the drug’s label, and in the accompanying medication guide.

Actos Side Effects and Potential Injuries
The FDA’s latest Actos warning follows another warning issued in June of 2007. At that time, the agency issued a "black box warning" requiring the manufacturers of Actos and Avandia (known as thiazolidinediones) to include warnings alerting patients and their doctors of cardiovascular and liver problems linked to the drug. Black box warnings appear on the packaging of drugs and are the strongest action taken by the FDA short of a recall.

These warnings were issued after the findings of a Cleveland Clinic study showed that thiazolidinedione use increased the risk of heart attack by as much as 42 percent. The findings also showed an increased risk of hepatitis, liver inflammation, elevated liver enzymes (an indication of liver damage) and liver failure.

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