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Actos Bladder Cancer the Latest Blow to Takeda

Sarah Klein | September 6th, 2011

Actos lawyers are already fielding hundreds of calls about alleged cases of Actos bladder cancer. Since the FDA’s June 2011 warning about this risk for those taking the drug for more than a year, news about the fallout has flooded the airwaves. Might Actos manufacturer Takeda soon set aside money to handle potential upcoming Actos settlements?

Actos considered the “safer” diabetes drug until now

Actos was approved by the FDA as a type-2 diabetes drug in 1999, but since then has gradually been associated with serious side effects, including an increased risk of fractures, particularly for women, and an increased risk of heart failure. A similar diabetes drug, Avandia, took the brunt of the press, however, because of studies that showed it increased risk of heart failure by as much as 43 percent. Some studies showed Actos to have a lower risk of heart failure, so many doctors switched from Avandia to Actos.

In 2010, however, the FDA announced it was looking into a possible link between Actos and bladder cancer. Early studies had suggested a connection. This year, after reviewing data from a 10-year Takeda observational study, the FDA concluded that overall, Actos presented no increased risk of bladder cancer, but for those taking the drug longer than a year—or who took higher doses—the increased risk was a startling 40 percent.

France issues an Actos recall

About the same time, data from the French National Health Insurance Plan also showed an increased risk of Actos bladder cancer, and France has now issued an Actos recall. Germany quickly advised it’s physicians to refrain from using the drug, and other countries are busy examining the data. Scientists say more studies need to be done, but the wave of new Actos lawsuits may indicate that several people have already fallen victim to Actos bladder cancer.

Actos lawsuits on the rise

Actos lawyers are claiming that Takeda should have known long ago that long-term use of Actos increased the risk of bladder cancer. According to the Associated Press, already more than 100 patients have come forward to discuss potential Actos lawsuits. As awareness grows, that number is expected to increase several-fold.

The updated Actos label warns doctors not to use Actos in patients with bladder cancer and to be careful with those patients who have a history of bladder cancer, but critics feel these warnings are still not enough to adequately protect consumers. The FDA has promised to continue reviewing the data, but so far has given no indication of a potential Actos recall in the U.S. Meanwhile, the European Medicines Agency (EMA) has called for a six-month review of every patient on Actos.

GlaxoSmithKline, makers of Avandia, has already set aside millions for Avandia lawsuit settlements. Actos lawyers speculate that depending on future research and the outcome of the initial Actos lawsuits, Takeda may soon be forced to do the same.