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Another Study Ties Actos to Higher Bladder Cancer Risk

Jul 5, 2012 | Parker Waichman LLP

A new study published in the Canadian Medical Association Journal has found that diabetics who use Actos (pioglitazone) face a higher risk of developing bladder cancer.  The publication of the study comes just a little over a years since the Actos label was updated to warn that patients who take the drug long-term may be more likely to develop bladder cancer.

Type 2 diabetes already boosts bladder cancer risk by 40%.  This new study involved a meta-analysis of 10 earlier studies of thiazolidinediones, the class of medications to which Actos belongs.    Taken together, they included 2.6 million people, including a group of 3,643 people were newly diagnosed with bladder cancer.

Only one of the studies included in the analysis found no heightened risk of bladder cancer.  But taken together, the remaining studies found that people taking thiazolidinediones had a 15% increased risk of developing bladder cancer, which was attributed to use of Actos.   Overall, the analysis found a 22 percent increased risk of bladder cancer with the use of Actos

Though the overall risk of developing bladder cancer is still small, the study authors advised that patients and doctors should still consider these risks when choosing a type 2 diabetes treatment.

"Although the absolute risk of bladder cancer associated with pioglitazone was small, other evidence-based treatments for type 2 diabetes may be equally effective and do not carry a risk of cancer," they wrote.

Last June, the U.S. Food & Drug Administration (FDA) issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries over the summer. Takeda Pharmacueticals officially recalled Actos from the French market in July 2012.

Since then, Takeda‘s revenues have dropped from their peak of $5 billion in 2010, partly due to safety concerns.  The company has also been hit with personal injury lawsuits by people who allege they developed bladder cancer because of Actos.  Some legal experts expect 10,000 such lawsuits could eventually be filed in the U.S.

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