Ongoing FDA Safety Review Reveals Increased Risk of Bladder Cancer for Actos Users

By Blume Forte Fried Zerres & Molinari on September 19, 2011

According to the American Diabetes Association, millions of people have been diagnosed with type 2 diabetes in the U.S.

Actos, or pioglitazone, is manufactured by the Takeda Pharmaceutical Company, and is used to help regulate blood sugar in adults with type 2 diabetes mellitus. Based on data provided by the U.S. Food and Drug Administration (FDA), from January 2010 through October 2010, about 2.3 million patients filled a prescription for a pioglitazone-containing drug.

After reports of a possible connection between Actos and an increased risk of bladder cancer, the (FDA) began conducting a 10-year epidemiological study of Actos and pioglitazone. In a safety announcement from September 2010, the FDA concluded that there was “no statistically significant association between Actos exposure and bladder cancer risk.”

Within less than a year of the 2010 safety announcement, the FDA released another; this time warning the public of an increased cancer risk. Further study of Actos-use and the development of bladder cancer revealed that long-term Actos users, who have been using the drug for at least one year, are indeed at an increased risk of developing bladder cancer, especially if they have a history of the disease.

The FDA has now required that the risk of bladder cancer be added as a warning on the drug label for Actos and other pioglitazone-containing drugs.

Since the drug manufacturer had not warned patients of an increased cancer risk, they may be legally liable for the harm caused to patients who took Actos and acquired bladder cancer.

Pharmaceutical companies are required to thoroughly test and properly label their products with adequate warnings. Failing to do so increases the risk of injury and illness to unknowing consumers. The New Jersey unsafe drug attorneys at Blume Forte have experience in successfully pursuing meritorious claims for defective drug products. We can help investigate your possible claim if you were harmed by an unsafe drug. Contact us for a no-cost consultation at 973-635-5400.

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