June 1, 2012 — The evidence linking Actos (pioglitazone) to bladder cancer continues to increase. A study published in the British Medical Journal has fond that people who take Actos at any time have an 83% increased risk of bladder cancer, and taking the drug for at least two years doubles the risk of bladder cancer. The risk is still low, but the researchers estimate that this translates to an extra 137 cases of bladder cancer per 100,000 people taking Actos.
Actos is a medication used by people with Type-2 diabetes to help them control their blood sugar levels. Despite the fact that it has been associated with an increased risk of bladder cancer and heart failure, health authorities have decided to keep it on the market.
This most recent study was conducted by a Canadian team of researchers, who analyzed data on 115,727 people in the U.K. with Type-2 diabetes who began therapy between 1988 and 2009. The researchers found that taking Actos at any time was associated with an 83% higher risk of bladder cancer.
The researchers were concerned that the risk of bladder cancer was under-estimated during the earlier observational studies. They advised that doctors, patients, and regulatory agencies should carefully weigh this information when deciding the risk-benefit profile of using Actos.
The experts who conducted the study had this to say about the study: “It can confidently be assumed that pioglitazone increases the risk of bladder cancer. It also seems that this association could have been predicted earlier.”
The maker of Actos, Takeda Pharmaceuticals, is accused of covering up research that suggested an early link between Actos and severe side effects, especially congestive heart failure. According to a whistleblower lawsuit filed against the company, researchers were instructed to hide findings which negatively reflected side effects of Actos. Takeda is also facing up to 10,000 Actos lawsuits from people who suffered serious side effects, especially bladder cancer.
The researchers concluded by warning that Actos’s benefits of reducing cardiovascular events in Type-2 diabetes patients remains questionable.
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