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Studies Lead to 2011 Warning of Actos Bladder Cancer

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Many patients who used Actos and developed bladder cancer didn't realize until June 2011 that their diabetes medication might be to blame. That was the month the FDA released a safety announcement stating that patients taking the medication for longer than a year may be at an increased risk of the developing bladder cancer. The agency based its conclusions on the five-year results of an ongoing epidemiological study that showed the use of Actos for over 12 months resulted in an astonishing 40 percent increased risk of bladder cancer.

After that announcement, Actos lawyers saw a large increase in plaintiffs desiring to file a lawsuit against manufacturer Takeda Pharmaceuticals. Since then, the number of cases has continued to increase, with all federal Actos lawsuits recently centralized in the Western District of Louisiana and cases filed in state courts across the country.

Early Studies Show a Connection Between Actos and Bladder Cancer

The FDA approved Actos in 1999 for its ability to help control blood sugar levels in patients with type 2 diabetes. Prior to that approval, however, a two-year animal study showed drug-induced tumors in rats receiving the equivalent of a human clinical dose. Actos lawyers argue that more studies should have been done at that point to further evaluate the safety of the medication.

In 2005, the PROactive three-year study, which examined cardiovascular outcomes of Actos use, showed patients taking the drug were more likely to be diagnosed with bladder cancer than those taking other similar medications. This information was not included in the final published paper or on Actos labels.

FDA Evaluates Actos Bladder Cancer

Later, on September 17, 2010, the FDA announced they were going to review the ten-year ongoing study conducted by Kaiser Permanente to evaluate the potential association between Actos and bladder cancer. Meanwhile, in early 2011, the American Diabetes Association published a study in Diabetes Care that analyzed reports made to the FDA between 2004 and 2009. Researchers concluded that in agreement with clinical studies, their analysis also showed an association between the drug and bladder cancer, and that the issue required further study.

The U.S. wasn't the only country looking into this association. On June 9, 2011, the French Medicines Agency announced its decision to suspend the use of Actos in France while awaiting the outcome of an ongoing European review. Their decision was based on a study in France using data from the French National Health Insurance Plan, which showed a statistically significant increase in the risk of bladder cancer in men exposed for more than a year. Takeda agreed to a voluntary recall of Actos in France in July 2011.

After reviewing the results of the French study, Germany advised their physicians to be cautious, as well, and not to write any new prescriptions for the drug.

Flood of Actos Lawsuits

Though the FDA did not encourage an Actos recall, their 2011 warning prompted a number of Actos lawsuits. The consumer advocacy group Public Citizen added to the awareness by including Actos on their list of "Do Not Use" medications, making it clear that they believed the risks of side effects outweighed any health benefits.

Many plaintiffs filed lawsuits in federal court, seeking in excess of $75,000 in damages. Those federal cases were consolidated into the Western District of Louisiana on December 29, 2011, establishing the Actos multidistrict litigation (MDL). California has also consolidated lawsuits filed in their state into one court to increase efficiency in pretrial processes.