Actos (pioglitazone), manufactured by Takeda Pharmaceuticals and distributed by Eli Lilly and Company, has been under FDA review since September 2010. In June 2011, the FDA issued a warning for Actos, while at the same time drug regulators in France and Germany suspended use of the drug, after it was linked to an increased risk for the development of bladder cancer.

Following its review, the U.S. Food and Drug Administration (FDA) approved updated warning labels for Actos, a prescription medication used to treat Type 2 diabetes. The updated label states that Actos usage for more than one year may cause bladder cancer.

The FDA reported in its data summary that “the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure.”

Actos quickly became one of the top-selling drugs in the United States after it received FDA approval in July 1999. However, in June 2011, the FDA warned that patients taking Actos for one year or longer were exposed to a risk of bladder cancer 40 percent higher than those who hadn’t taken the drug and ordered Takeda to include a warning about the increased risk of bladder cancer on the drug’s labeling.

Most recently, a Canadian study led by Montreal epidemiologist Dr. Laurent Azoulay and published online in the British Medical Journal found that patients who take Actos two years or longer are twice as likely to develop bladder cancer as those who have never used the drug. The study analyzed the medical records of nearly 116,000 patients in the U.K.

Actos lawsuits filed in federal courts have been consolidated for pre-trial proceedings under Judge Rebecca Doherty in U.S. District Court for the Western District of Louisiana. Lawsuits claim Takeda and Eli Lilly misrepresented and omitted information it held about Actos and “actively concealed its risks.” The lawsuits also claim Plaintiffs were not adequately warned about Actos’ risks and could have taken several safer alternative drugs had they known about the health risks posed by Actos.

Beasley Allen is currently investigating claims involving usage of Actos, Actoplus Met, Actoplus Met XR, Duetact and bladder cancer.



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