Actos and Bladder Cancer | Actos Recall

Wrongful Death Suit Filed Against Actos Manufacturer

Shay Morrigan | June 19th, 2012

Louisiana resident Sandra Williams, individually and as next-of-kin Gloria O’Neal (deceased), has filed a lawsuit against Actos manufacturer Takeda Pharmaceuticals. According to her complaint, O’Neal suffered serious injuries as a result of taking Actos that led to her death.

As have other Actos lawyers, Williams’ attorney claims that Takeda is liable for O’Neal’s injuries, as they were aware of the link between Actos and bladder cancer, yet failed to warn the public or medical professionals of the risks.

Williams brings counts of liability, negligence, and wrongful death. She seeks in excess of $50,000 in damages.

Decedent unaware of connection between Actos and bladder cancer

O’Neal was prescribed and began taking Actos upon direction of her physician for the long-term maintenance of her type II diabetes. Williams claims in her case that as a result of ingesting Actos, O’Neal was diagnosed with bladder cancer and died on October 23, 2011.

She goes on to state that had O’Neal known about the reports and studies linking Actos and bladder cancer, she would not have used the drug. She died without knowing that her bladder cancer could be related to her diabetes medication.

Actos lawyers note studies linking the drug with the disease

As the number of Actos lawsuits filed around the country continues to increase, many Actos lawyers have noted the studies linking Actos to bladder cancer. Williams’ lawyer notes that prior to Actos approval by the FDA in 1999, animal studies indicated potential for carcinogenicity. In 2005, researchers conducting the three-year PROactive study became aware that those patients taking Actos had a significantly higher risk of bladder cancer than those taking other diabetes drugs.

On September 17, 2010, the FDA announced it was undertaking a review of the data from an ongoing, ten-year epidemiological study evaluating the potential association between Actos and cancer. The analysis demonstrated that the risk of bladder cancer increases with increasing dose and duration of Actos use.

On June 9, 2011, the European Medicines Agency announced that it had been informed by the French Medicines Agency of its decision to suspend the use of Actos and similar medications.

France implements an Actos recall

French researchers had been examining data from the French National Health Insurance Plan, and determined that males taking Actos for longer than a year were at a significantly increased risk of bladder cancer.

Meanwhile, on June 15, 2011, the FDA announced that using Actos for more than one year be associated with an increased risk of the disease. They noted that in the 10-year study, those taking Actos for longer than a year were 40 percent more likely to be diagnosed with bladder cancer.

In July 2011, Takeda implemented a complete Actos recall in France. There has been no such Actos recall in the U.S. to date, however.