Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent

Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer.  This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.

According to a report from Healthday News, the study, conducted by researchers at the University of Alberta School of Public Health in Canada, consisted of an analysis of 10 previously completed studies involving 2.6 million people. From that group, 3,643 people were newly diagnosed with bladder cancer. Combined, the analysis found a 15 percent increase in the risk of bladder cancer with the use of thiazolidinediones, which according to Healthday News, the authors attributed to the use of Actos. Overall, they found that diabetics – a group already at a higher risk for developing the disease – had a 22 percent increased risk of bladder cancer if they took Actos.

This isn’t the first time a study has linked Actos to an increased risk of bladder cancer.  In May, a study published in the British Medical Journal found that patients taking Actos had an 83 percent increase in the relative risk for bladder cancer. The risk increased for patients who took Actos longer, and who were exposed to the highest cumulative dose.

On June 15, 2011, 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. The June safety communication was a follow-up to one the agency issued in September 2010 after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer rises with increasing dose and duration of Actos use, reaching statistical significance after 24 months.

That same month, after a separate study commissioned by French regulators demonstrated an increased risk of bladder cancer associated with Actos in people who took it the longest and at the highest cumulative dose, the  French and German governments decided to suspend sales of Actos in those countries. On July 12, 2011, Takeda Pharmaceuticals officially recalled Actos from the market in France.

Since the FDA issued its Actos bladder cancer warning, Takeda Pharmaceuticals has been named in a number of U.S. lawsuits that accuse it of concealing knowledge of Actos’ bladder cancer risks and failing to adequately warn consumer and health care providers about its association with bladder cancer.  Most Actos bladder cancer lawsuits have been consolidated in a multidistrict litigation in U.S. District Court, Western District of Louisiana. As we’ve reported previously, some legal experts estimate that Takeda could face as many as 10,000 Actos bladder cancer lawsuits in the U.S.

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