Pioglitazone Reviewed By FDA – Potential Bladder Cancer Risk

Pioglitazone Reviewed By FDA – Potential Bladder Cancer Risk – The FDA is currently studying a possible link between pioglitazone (Actos) and bladder cancer, following preliminary data from a 10-year epidemiological study sponsored by Takeda. Due to the possible link being found with pioglitazone, both thiazolidinediones — pioglitazone and rosiglitazone (Avandia) are going to be reviewed.

Pioglitazone is used by type 2 diabetes sufferers, and in the study done more than 193,000 patients were studied. In these patients, there was no statistical difference between users and non-users in regards to bladder cancer. However, “the risk of bladder cancer increased with increasing dose and duration of [pioglitazone] use, reaching statistical significance after 24 months of exposure.”

Also, it was said in the study by the FDA that “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.”

Robert Spanheimer, MD, Takeda’s medical director for pioglitazone, spoke about this review, saying that this study was more of a hypothesis than an actual fact, and that more proof was needed to show any correlation between pioglitazone and bladder cancer. In regards to Takeda, Spanheimer said Takeda “is interested in safety, as is the FDA.”

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