Scientific Studies Link Actos to Bladder Cancer
There have been a number of epidemiological studies of pioglitazone and its side effects. Several studies have cited a statistical link between the prolonged use of pioglitazone and an increased risk of bladder cancer.
Takeda has been aware of the link between the diabetes drug and bladder cancer since 1999 when Takeda was busy testing the drug in order to present it to the FDA for approval. Animal studies at the time suggested that pioglitazone was linked to an increased risk of bladder cancer. Actos was approved in 1999 by the FDA without any warning or alert of this risk printed anywhere in the labeling of the drug.
Since then, a number of studies have raised concern about the diabetes drug’s dangerous side effects. The following studies found a link between pioglitazone and cancer:
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A study conducted in 2002 found a link between pioglitazone and bladder cancer. The study, published in Southern Medical Journal was designed to review the benefits and risks of Thiazolidinediones (TZDs) like Actos. According to researchers, several animal studies and clinical trials suggested that TZDs may induce cancer.
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Results from a study called the PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events) funded by Actos manufacturer Takeda Pharmaceuticals, were presented in late 2005. The study showed 16 cases of bladder cancer reported from patients given Actos, which was four times higher than those who received other drugs. In 2006, the FDA required Takeda to include these bladder cancer reports on the Actos label.
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A study conducted by France's health insurance agency (Caisse National d’Assurance Maladie), made public on June 7, 2011 prompted France and Germany to withdraw pioglitazone-containing medication from pharmacies.
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French researchers found that patients taking pioglitazone were more likely to have bladder cancer than those not taking the drug. Additionally, those taking higher dosages of pioglitazone were shown to be at a higher risk for bladder cancer.
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A 2011 study published in Diabetes Care has presented data that suggests prolonged use of pioglitazone (longer than 2 years) can increase the risk of developing bladder cancer.
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