FDA Warnings For Actos Bladder Cancer Came Too Late For Some

Lafayette, LAGiven the prevalence of Type 2 diabetes in the US the need for, and use of medication to control the condition for those individuals unable to manage their diabetes through natural means, is a foregone conclusion. And while rare is a medication that does not have a basket of side effects, Actos patients thinking they were doing the right thing in managing their diabetes would have been shocked to learn of Actos side effects that had the potential for ending their lives prematurely.

Actos heart failure is one such adverse reaction. The risk for cardiovascular events has always been a known factor involving Actos, although the risk was thought to be lower than some of Takeda Pharmaceutical's competitors, including GlaxoSmithKline's Avandia.

Actos bladder cancer, until recently, was not on the radar.

It is now. Actos has been banned in two countries due to the bladder cancer risk. And the US Food and Drug Administration (FDA) in June 2011 issued a warning with regard to Actos and bladder cancer, citing a study that found use of Actos for more than one year translated to a 40 percent risk for bladder cancer.

That warning came too late for the deceased man at the center of a lawsuit filed November 16 of last year in US District Court for the Eastern District of Louisiana, Lafayette Division. The Actos bladder cancer lawsuit is part of the Actos multidistrict litigation (MDL No. 6:11-md-2299) and was filed in behalf of the man's widow.

The complaint alleges the man, whose identity was not published, started on Actos for Type 2 diabetes in 2004. After taking Actos continuously for five years, the man developed bladder cancer in 2009 and passed away in October 2010.

The man's use of Actos to treat his diabetes over a period of five years is four years longer than the FDA recommendation, in order to avoid a dramatic risk of bladder cancer. The man died a year before that warning was issued, and was diagnosed with bladder cancer two years prior.

The Actos lawsuit claims the man would never have consented to use Actos had he and his wife been aware of the potential for grievous side effects. To that end, it is a common refrain amongst Actos lawsuits that plaintiffs were not aware of the risks, and blame Takeda for either failing to be aware of the risks, or failure to inform about risks known to them.

The Actos bladder cancer lawsuit is Case No. 6:12-cv-02886-RFD-PJH.