June 1, 2012 — Adding more data to a growing volume of evidence linking Actos (pioglitazone) to bladder cancer, the British Medical Journal has published a study linking the Type-2 diabetes drug to at least an 83% increased risk of bladder cancer. The researchers also found that the longer the duration of Actos treatment, the higher the risk of bladder cancer. People who had taken Actos for at least two years had twice the risk of bladder cancer, translating to an extra 137 cases per 100,000 person years.
Takeda Pharmaceutical’s Actos is a medication for people with Type-2 diabetes, and it works by helping them control blood sugar levels. Even though Actos has been linked to heart failure and bladder cancer, it has not been recalled and it is still on the market.
The study that was published most recently was performed by a group of Canadian researchers. They analyzed data from people in the United Kingdom who had Type-2 diabetes and began treating their disease between 1988 and 2009. One of the most striking findings was that taking Actos at any time increased the risk of bladder cancer by 83%. Even more striking, people who had taken Actos for at least two years had twice the risk of having bladder cancer.
The researchers found that the link between Actos and bladder cancer may have been under-estimated during the early clinical studies before Actos was approved. Furthermore, they cautioned that doctors, patients, and regulatory agencies should consider the risks of Actos versus the benefits, especially when there are nearly a dozen classes of diabetes medications already on the market.
The authors of the study wrote in an accompanying editorial, “It can confidently be assumed that pioglitazone increases the risk of bladder cancer. It also seems that this association could have been predicted earlier.”
Indeed, early studies may have actually identified serious side effect of Actos. Takeda is now facing a whistleblower lawsuit from its employees, who claim that they were told to cover up results of studies that linked Actos to congestive heart failure. Takeda is also facing up to 10,000 Actos lawsuits from people who suffered serious injuries after taking the drug.
The researchers further warned that the benefits of using Actos for reducing cardiovascular events remains questionable.
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