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Last week the first of what will likely be thousands of lawsuits against the manufacurer of Actos was filed on behalf of a Pennsylvania hospital secretary who was diagnosed with bladder cancer in 2009 after taking Actos for more than a decade. The plaintiff in this Actos lawsuit is 54 years old and is concerned that she may lose her bladder and need chemotherapy.

Actos is manufactured by a Japanese company, Takeda Pharmaceuticals Co., Ltd. Takeda halted sales of Actos in June in Germany and France as a result of pressure from those countries’ regulators. Here in the U.S., the FDA took a less aggessive approach, issuing a warning about the risk of bladder cancer from Actos, but allowing sales to continue. The FDA reported that the risk of bladder cancer was 40% higher for patients taking Actos for a at least one year.

This development is a big blow to Takeda. Actos became the number one diabetes pill after Avandia was found in 2007 to significantly increase the risk of heart attack. Avandia was banned in the European Union and restricted in the U.S. As a result, Actos sales were $4.3 billion in 2010.

This increased risk is also a blow to diabetes patients to whom Actos was a very appealing option. Patients took one Actos pill per day, which controlled their blood sugar with few immediate side effects. The drug also reportedly improved the body’s sensitivity to insulin and allowed some patients to reduce or delay their insulin use.

Whatever the outcome of the Actos litigation, diabetes patients and their doctors will have to consider carefully their options. Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, said more long-term data on the effects of Actos is needed.

"The consensus already is that (Actos) should only be considered … after patients have exhausted all other options."

If you take Actos, you should speak with your prescribing doctor and weigh the risks and benefits of continuing the drug.

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