A link between the diabetes medication Actos® (pioglitazone) and the risk of getting bladder cancer has regulatory agencies in three countries concerned. France and Germany banned the sale of the drug because of the possible bladder cancer link, and in the United States, the Food and Drug Administration (FDA) released a safety announcement saying patients taking Actos® for more than a year were at an increased risk of developing bladder cancer.

France took action following the release of results from a three-year study of the drug in diabetes patients. Germany followed suit. Five days later, on June 15, 2011, the FDA put out its safety announcement.

The French study showed a dose-response effect, meaning that the longer a patient is exposed to the drug, the greater his or her chance of getting bladder cancer becomes. The U.S. study involved 193,000 patients taking Actos®. Those on Actos® were compared to a control group that had not taken the drug. In the Actos® group of patients, those who took the drug for over a year had a 40 percent higher risk of bladder cancer compared to patients who had never taken the medication.

Bladder Cancer Symptoms

If you are taking Actos® and experience symptoms of bladder cancer, you should visit your doctor right away. The most common symptom of bladder cancer is blood in the urine. The blood usually is visible to the patient, but in some cases may be seen only under a microscope. The blood is seen at intermittent intervals, and is not associated with pain.

Other symptoms include:

• Burning upon urination
• Frequent urge to urinate only small amounts
• More rarely, in cases of advanced disease, patients may cough up blood (when the cancer has spread to the lungs), have a distended bladder, pain in the sides of the legs or bone pain

FDA Warning: Actos® Linked to Bladder Cancer

The FDA published a safety warning June 15 saying:

"Use of the diabetes medication Actos® (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer."

The agency said the medication label as well as the patient Medication Guide will be updated with the new information. The announcement was based on a review of results from a five-year interim analysis of an ongoing ten-year epidemiological study. The drug manufacturer Takeda is conducting the research.

FDA recommendations for healthcare professional include:

• Not to use Actos® in patients who have bladder cancer
• Use the medication cautiously in those with a history of bladder cancer
• Weigh the benefits of using the drug against the risks of recurrence in patients with a history of the disease

Contact an Actos® Bladder Cancer Lawyer

If you've taken Actos® to control your diabetes and subsequently contracted bladder cancer, you should contact a bladder cancer lawyer for help. You might qualify for compensation.