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FDA Receives 1,025 Actos Bladder Cancer Reports Since 2011

FDA Receives 1,025 Actos Bladder Cancer Reports Since 2011

October 15, 2012 — According to the QuarterWatch report from the Institute for Safe Medication Practices (ISMP), a consumer safety research group, the type-2 diabetes drug Actos (pioglitazone) has been associated with 1,025 reports of bladder cancer since the beginning of 2011. In the first quarter of 2012, there were 235 new cases of bladder cancer. The ISMP said that this “surge of reports” may be due to increased awareness about the risk of bladder cancer. Furthermore, it highlights the “extremely slow and uncertain process through which the cancer risks of prescription drugs are identified and their significance assessed.”


Concern about the link between Actos and bladder cancer has been growing since clinical trials were performed in 1999. Takeda Pharmaceuticals, the company that manufactures Actos, conducted high-dose studies of Actos in rodents. The rats did not tolerate high doses of Actos very well. Researchers noted an increased risk of cardiovascular problems and calcium nodules in the bladder, which may have contributed to an increased risk of bladder cancer.

Before the U.S. Food and Drug Administration (FDA) approved Actos, they required warnings about a potential increased risk of bladder cancer in the prescribing information for physicians. They also required Takeda to conduct a 10-year safety study. The preliminary 5-year results reported an increased risk of bladder cancer among people who used Actos for at least two years. At the same time, French researchers found an increased risk of bladder cancer. French and German health authorities suspended sales of the drug. However, the FDA and the European Medicines Agency (EMA) have not recalled Actos or restricted sales of the drug.

As awareness has grown regarding the link between Actos and bladder cancer, the popularity of the drug has declined. In 2010, Actos was prescribed most frequently for people with type-2 diabetes. However, by the first quarter of 2012, prescriptions fell 38% to 1.8 million.

The growing awareness may be one reason why there has been a “surge of reports” of bladder cancer linked to Actos. The ISMP called this a “feedback loop,” which involves researchers, government regulators, physicians, and law firms who are all concerned about life-threatening drug side effects. Although the data linking Actos to bladder cancer is still ambiguous, the growing number of adverse events is an important warning sign when evaluating the risk of cancer associated with this drug.

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