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Actos Bladder Cancer Bellwether Trial Starting Today in Federal Court

Feb 3, 2014

Actos, a diabetes medication that was approved by the U.S. Food and Drug Administration (FDA) in 1999, and which is manufactured by Takeda Chemical Industries, is at the center of an Actos multidistrict litigation (MDL) trial that is starting today.

The active ingredient in Actos is pioglitazone hydrochloride and is approved for the treatment of Type 1 and Type 2 diabetes, Type 1 diabetes mellitus, diabetes mellitus inadequate control, and high blood pressure, and is provided in the following versions:

  • ActosPlus Met: active ingredients metformin hydrochloride and pioglitazone hydrochloride
  • ActosPlus Met XR: active ingredients metformin hydrochloride and pioglitazone hydrochloride
  • Actos: active ingredient pioglitazone hydrochloride
  • Due Tact: active ingredients glimepiride and pioglitazone hydrochloride
  • Pioglitazone: active ingredient pioglitazone hydrochloride
  • Pioglitazone hydrochloride and metformin hydrochloride: active ingredients metformin hydrochloride and pioglitazone hydrochloride

Actos has been the subject of a number of research studies which have found an association with the drug and serious adverse health reactions. For example eHealthme conducted a study in May 2013 to review Actos and potential, associated bladder cancer risks. In all, 29,989 Actos users participated in the study, which also utilized reports from the U.S. Food and Drug Administration (FDA), which is regularly updated. Of those participants who were taking Actos, 1,631 people developed bladder cancer. The greatest concentration was seen in 39-48 percent of the group who had taken Actos for 2-5 years prior to developing bladder cancer. The next largest group, 32.17 percent, developed bladder cancer after taking Actos for 5-10 years.

Prior, in June 2011, medical regulators in France and Germany suspended the sales of Actos in their countries over the potential bladder cancer risks associated with Actos. The announcements followed a French Medicines Agency-commissioned study which revealed that people taking Actos were likelier to develop bladder cancer, an aggressive cancer. The study on which the announcement was based looked at cancer rates in 155,000 people taking Actos in France from 2006-2009 and 1.3 million other people who were diagnosed with diabetes, but who were not taking Actos. The study revealed that bladder cancer risks were 22 percent greater in the group of people taking Actos. In fact, the risk was greatest in people taking a 28,000-mg cumulative dose.

That same month, the FDA announced a review of Actos for potential bladder cancer risks based on a September 2010 safety review. The agency indicated that preliminary data from a 10-year study submitted by Takeda, did not indicate a statistically significant association between Actos exposure and increased bladder cancer risks; however, some evidence indicates that Actos patients who take the drug for at least two years or at the highest cumulative dose, faced increased bladder cancer risks.

Another study, released in May 2011, reviewed adverse event reports sent to the FDA between 2004 and 2009 that suggested that Actos patients faced a “disproportionate risk” of developing bladder cancer. That study reviewed a-half million side effect reports involving people taking various diabetes medications and also found that one-fifth of those reports involving bladder cancer also involved Actos

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