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Sheller, P.C.
Sheller, P.C.
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Actos and Elevated Bladder Cancer Risk

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An increased risk of bladder cancer has been linked to Actos (Pioglitazone), an anti-diabetic drug, manufactured by Takeda Pharmaceuticals.

First approved in 1999, Actos works to help reduce sugar in patients with type 2 diabetes. Controlling high blood sugar helps prevent a host of health issues including kidney damage, blindness, nerve problems and loss of limbs among others. Proper control of diabetes may also lessen the risk of a heart attack or stroke.

FDA Involvement

In 2011, the U.S. Food and Drug Administration (FDA) issued a safety alert requiring a label change to Actos to address the risk of bladder cancer for users taking the drug for more than a year or for taking the greatest dose. The agency’s announcement that Actos use can lead to a 40 percent increased risk of bladder cancer stemmed from a study of 200,000 patients with Type 2 diabetes.

Sales of Actos were suspended by The French Medicines Agency following a study by the French Health Insurance that linked Actos to bladder cancer. Regulators in Germany have halted new Actos prescriptions pending more studies while the European Agency (EMA) started a review in 2011 that is yet to be concluded.

Actos Lawsuits

Lawsuits against Takeda Pharmaceuticals have already begun to mount in the U.S. According to the FDA, 2.3 million patients filled Actos prescriptions from January to October 2010. Based on the 40 percent increased risk of bladder cancer, the amount of people at risk for developing bladder cancer since FDA approval in 1999 could easily be in the thousands. Legal experts anticipate several thousand more lawsuits in the future.

Lawsuits filed by people that suffered injury by Actos list several counts including failure to warn about side effects and willfully concealing the safety concerns associated with the drug.

What Patients Should Do

If you or anyone you know takes Actos and has experienced these symptoms, you should consult your health care provider immediately to check for bladder cancer:

• Blood in the urine
• Urgent need to urinate
• Pain while urinating
• Frequent urination, or feeling the need to urinate but with no results
• Pain in the abdominal (stomach) area or in the back

In 2012, 29.1 million Americans, or 9.3% of the population, had diabetes, according to the American Diabetes Association. Of that number, 21.0 million were diagnosed, and 8.1 million remained undiagnosed.