What is the problem with Actos?
On June 15, 2011, the U.S. Food and Drug Administration (FDA) issued a safety alert informing the public that using the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer.
Information about the bladder cancer risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.
More than 60,000 new cases of bladder cancer are diagnosed every year in the United States.
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The safety alert is based on a review from an ongoing 10-year study. At the 5-year interval, results showed that although there was no overall increase of bladder cancer from Actos – there was an increased risk of bladder cancer noted among patients who had the longest exposure to Actos and were exposed to the highest cumulative dose of Actos.
In France, a study was done that suggests an increased risk of bladder cancer from Actos; France has suspended the use of Actos and Germany makes the recommendation to not use Actos on new patients.
As per the safety alert, the “FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.”
In the meantime, how many type 2 diabetic patients will suffer from bladder cancer after long term exposure to Actos? Do you have an Actos bladder cancer claim?