Actos Safety Review, Bladder Cancer Risk

The Actos Safety Review: What is it all about?

In September 2010, the Food and Drug Administration ordered a safety review of Actos based on preliminary data indicating a possible risk of bladder cancer. The FDA is reviewing data from an ongoing ten-year study to evaluate bladder cancer risk, after findings in animal and human studies suggested a need for further evaluation. The ten-year study is observing the long-term risk of bladder cancer associated with Actos in approximately 193,000 diabetic patients. The five-year results so far have shown no overall increased risk of bladder cancer from Actos use.

Takeda Actos

However, a significantly increased risk of bladder cancer has been associated with patients taking the highest Actos dosages and with patients taking Actos over the longest periods of time. Based on its safety review, the FDA has required updated Actos drug label warnings and is informing the public that taking Actos for more than one year may be associated with an increased risk of bladder cancer.

The FDA will continue to update the public on the results of its review and as new data becomes available.

 

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Recent Articles and Publications

 
April 25, 2012
Recovering From Actos-Related Bladder Cancer: Part 1of 2: How Can I Prevent a Recurrence?
Actos, or pioglitazone, is a prescription medicine used in the treatment of Type-2 diabetes and works by sensitizing cells to the pancreas-produced hormone known as insulin. Insulin is used by the body to regulate the amount of sugar or glucose in the body therefore when cells are more sensitive to insulin, sugar in the blood naturally moves more easily into cells.
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April 23, 2012
Recovering From Actos-Related Bladder Cancer: Part 2 of 2: What All Actos Users Should Know:
Actos, a drug used in the treatment of Type 2 Diabetes has been shown to carry a risk of bladder cancer, particularly among those who are elderly or who have taken the drug in higher doses or for extended periods of time (longer than one year). Although the drug has not yet been recalled by the FDA, it has fallen under intense scrutiny and has been pulled from the French and German markets.
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March 03, 2012
Actos Discussions Part 2: Dangers of the Drug
Links to higher heart disease rates have been associated with the use of Actos, and, in fact, Actos may cause as many heart problems as GlaxoSmithKline’s drug, Avandia. The American Heart Association reported that studies showed patients taking either diabetes drug were at least four times as likely to experience heart attacks, heart failure or even death.
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