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FDA Updates Warnings and Precautions Section of Actos Label after French and German Regulatory Authorities Suspend Drug Due to Possible Increased Risk of Bladder Cancer

Updated: 8/14/21 11:00 amPublished: 7/5/11

On June 16, FDA officials provided an update on its safety review of Takeda’s Actos (pioglitazone), announcing that going forward, prescribing information for Actos will include the following FDA disclaimer: “…use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Takeda is currently working with the FDA to make these updates to Actos’ labeling. This followed regulatory authorities in France and Germany deciding, on June 10, 2011, to suspend sales of Actos over concerns that the medication could increase the risk of bladder cancer. The FDA’s decision is based on different data than the French study; namely, the interim five-year results of a ten-year study concluding in 2012 sponsored by Takeda. The data showed that while overall use of Actos was not linked with increased bladder cancer risk, those using high doses of the medication for longer periods were at a very slightly higher risk of bladder cancer – Diabetes Care, where the study was published, called it a “weak association” though it was statistically significant. Going forward, each year, the company will update the study. Interim reports will be submitted to the FDA on an annual basis.

For context, French and German regulatory authorities decided to suspend Actos from the market after the results of a French insurance database study of nearly 1.5 million patients showed a slight increase in the rate of bladder cancer among the more than 150,000 people taking Actos. While France and Germany decided to suspend Actos from the market, the verdict is still out in the rest of Europe and there is a meeting July 17 to further explore the data by a closed-door specially created special advisory group (SAG) that will meet in London. The European Medicines Agency (EMA; the European equivalent of the FDA) is currently looking over the available safety data on Actos, and is recommending that people using Actos continue their current therapy until its review is complete. The fact that they are recommending Actos and have moved so quickly with the group meeting in London suggests to us that the decision may well be one that suggests French concerns are overblown. That said, we have learned from experience not to jump to hasty conclusions when regulatory agencies are involved.  --AB

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