How Safe Is Actos?

Seattle, WAIt has been nearly three years since a study suggested that Actos was safer than rival drug Avandia, but in that time, concerns about Actos side effects have grown. Lawsuits have been filed alleging patients were put at an increased risk of Actos bladder cancer after using the medication, while a whistleblower has alleged the maker of Actos purposely hid damaging information about Actos diabetes medication.

On August 4, 2011, the US Food and Drug Administration (FDA) issued a warning that use of Actos (known generically as pioglitazone) for more than one year could be associated with an increased risk of bladder cancer. That information came from an interim review of a long-term study. A different study, conducted in France, also suggested a link between the use of Actos and the development of bladder cancer. Based on that information, France suspended the use of Actos while Germany recommended that new patients not be started on the medication.

Recently, concerns about the safety of Actos were raised by a whistleblower, Helen Ge, who alleged in a lawsuit that Takeda Pharmaceuticals, maker of Actos, failed to properly report adverse events associated with Actos to the FDA, as required.

Meanwhile, a lawsuit was filed in Louisiana, alleging a man developed bladder cancer after using Actos. The lawsuit claims Actos is an unreasonably dangerous and defective drug, and further claims that Takeda either knew or should have known about the risks associated with Actos use. The plaintiff, Timothy Plaugher, alleges Takeda failed to adequately warn patients about the dangerous link between the use of Actos and bladder cancer.

In a different lawsuit, a judge has appointed 19 plaintiffs' lawyers to manage ongoing Actos litigation.

Actos became a top-selling type II diabetes medication after Avandia sales were severely restricted by the FDA. That move came after Avandia was linked to an increased risk of heart attacks. The first hearings in the large-scale lawsuit were set to begin on March 22.