Actos Bladder Cancer Study - Consumer Justice Foundation

Actos Bladder Cancer Study

Written by Faith Anderson on July 11, 2012
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Actos and Bladder Cancer Side Effects

Actos (pioglitazone) was introduced by Takeda Pharmaceuticals and garnered FDA approval in 1999 for the treatment of type 2 diabetes in the United States. Actos is a once-daily pill that functions by increasing the body’s sensitivity to insulin, and medications that contain the same active ingredient as Actos include Duetact and ActoPlus Met. Despite the popularity of Takeda’s Actos, an emerging body of research has shed light on the significant link between the diabetes drug and the increased risk of devastating bladder cancer side effects.

Researchers involved in the study examined a number of biomedical databases, studies and trials that included data on 2,657,365 patients, 3,643 of which were diagnosed with bladder cancer. According to the results of the study, there is a 22% increased risk of bladder cancer among patients with type 2 diabetes who take Actos or another drug belonging to the same class of medications – called thiazolidinediones – which also includes drugs like Rezulin and the already recalled Avandia.

FDA Bladder Cancer Warnings and Actos Lawsuits

This new Actos bladder cancer research comes on the heels of two additional reports published several weeks ago, which also confirmed the link between Actos and bladder cancer side effects. In one study, researchers from the University of Pennsylvania also suggested that the bladder cancer risk may be linked to the thiazolidinedione class of drugs as a whole, but noted that the increased risk may be closer to 75%. Another study conducted by Canadian researchers limited the bladder cancer risk to Actos alone.

The FDA has been studying the potential connection between Actos and bladder cancer since September 2010, when the agency issued an Actos drug safety communication to consumers and healthcare providers in the U.S. A study conducted in France last year was the first to positively report an Actos-bladder cancer link, a discovery that led drug regulators in both France and Germany to initiate an Actos recall. The response by the FDA and in the European Union was to institute stronger Actos warnings on the drug label, but to ultimately keep the medication on the market. A growing number of former Actos patients are pursuing Actos lawsuits against Takeda after developing bladder cancer, claiming that the drug firm failed to adequately research the side effects of the medication or warn patients about its risks.

Posted Under: FDA - Food and Drug Administration
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