As you may have read from our previous post, the popular diabetes medication Actos has been linked to a possible increased risk of bladder cancer.
The FDA has been reviewing data about Actos for over a year, and has come to the conclusion that the risk is high enough to warrant a label change. Label changes require the drug’s manufacturers to warn patients and physicians in order to prevent injury.
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Here are a few resources from the FDA that help outline their history with this drug:
Announcement of Safety Review
In this correspondence, the FDA announced they had begun an investigation into whether Actos causes an increased risk of bladder cancer.
Safety Announcement from 2010
This announcement from when the review was still ongoing includes a data summary at the bottom that details some of the studies performed around Actos and bladder cancer risks.
Safety Announcement / Update on the Safety Studies
Published in June 2011, this announcement specifies that Actos may increase the risk of bladder cancer if used for more than one year. It states that the Warnings and Precautions label section of all pioglitazone-containing medicines like Actos will now include special information about this risk.
New Label Requirements and Other Actos Info
This page has links to the exact wording that now must appear on Actos labels, along with more information from the FDA about the drug and its risks.
Remember, if you’ve taken Actos for diabetes and been diagnosed with bladder cancer, you might be entitled to compensation, and we can help. Call us at 901-327-1212 or contact us through the website to talk with one of our attorneys for free about your case.