According to reports, the FDA is looking into a probable relation between pioglitazone (Actos) and bladder cancer. For this, thiazolidinediones -- pioglitazone and rosiglitazone (Avandia) are under scrutiny.
Subsequent to getting preliminary information from a 10-year epidemiological research funded by Takeda, the FDA started its assessment for pioglitazone. A provisional investigation of data was conducted that entailed over 193,000 patients suffering from type 2 diabetes.
It was found that there was hardly any major rise in bladder cancer amongst consumers of pioglitazone than the non-users. However, it was discovered that with the increased usage and duration of pioglitazone, the possibility of cancer boosted. After 24 months of continued use, the statistical significance in bladder cancer surged.
Today, Robert Spanheimer, MD, Takeda's Medical Director for pioglitazone told MedPage that the FDA declaration and the statistics from the epidemiological study should be regarded as provisional findings from a 10-year study.
In its statement of the safety assessment, the FDA wrote, "Results from two, three-year controlled clinical studies of Actos, the PROactive study and a liver safety study demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators".
The outcomes of PROactive are incorporated in the present pioglitazone label.
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