June 16, 2011—The U.S. Food and Drug Administration (FDA) warned Actos patients of an increased risk of bladder cancer associated with the diabetes drug. The warning comes after an analysis of an ongoing study assessing the safety and effectiveness of Actos.
A five year analysis of an Actos study initiated by Takeda Pharmaceutical Company revealed that patients who used the drug for more than a year, or took the highest doses, were more likely to develop bladder cancer.
In September 2010, the FDA started its safety review after preliminary data from the study suggested an association between Actos and bladder cancer. The FDA continues its review of Actos.
Actos also has come under scrutiny in Europe after a study in France demonstrated an increased incidence of bladder cancer. The drug has been banned in France in Germany.
If you have taken Actos and have concerns about the drug, promptly contact your physician for an evaluation. |