Date posted: 4/18/2012
June 15, 2011 – The FDA released a statement on its website today indicating it would require a label change for the popular diabetes drug Actos to show the drug carries risks of bladder disease.
The move follows years of testing here and in Europe over the drug’s safety and the decision last week by regulators in France and Germany to ban all new prescriptions of Actos.
A long running French study of more than 150,000 patients taking Actos showed that use of heavier doses for more than a year could increase the risk of bladder cancer by as much as 40%.
There is also an ongoing 10 year study of the drug here in the United States, which was ordered by the FDA as part of the approval process after early trials of Actos showed some safety concerns. Although only 5 years of data are available so far, experts say the results are troubling.
Takeda Pharmaceuticals will now have to add language to the warning label or “black box” label of Actos stating that long term use of the drug could increase the risk of bladder cancer.
According to FDA records, approximately 2.3 million people in the United States took Actos in 2010. Ironically, the growth in use of Actos was due to the increasing number of type II diabetes cases and health concerns over competing drug Avandia.
Takeda Pharmaceuticals released a statement that they remain “confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes.”