Toronto, ONThe headlines in Canada screaming the potential for Actos bladder cancer were loud and compelling, with the Canadian Broadcasting Corporation (CBC) carrying a report from the Associated Press (AP) that the manufacturer of the best-selling diabetes drug on the planet was facing hundreds of lawsuits over the association of Actos and bladder cancer. Plaintiff Nancy Rios was concerned she would lose her bladder.
And yet, this is hardly recent news. In fact, the CBC/AP report to which we refer was published nearly five years ago, in the summer of 2011 (CBC Health 8/5/11).
Much has happened since then. Plaintiffs fighting an Actos bladder cancer lawsuit continue to battle the manufacturer of Actos - Takeda Pharmaceuticals - over the potential for bladder cancer. The US Food and Drug Administration (FDA) has warned that the risk for bladder cancer increases after Actos has been used to treat type 2 diabetes for one year. And Takeda, in previous lawsuits, has been accused of harboring knowledge about the potential for bladder cancer but keeping that risk under wraps - and failing to preserve documentation related to the risk.
Actos, as most familiar with the file are aware, was the number two type 2 diabetes drug behind Avandia when the latter was vilified for posing cardiovascular risks. Actos is also thought to harbor a risk for Actos heart failure - however, the risk is less significant than that of GSK’s Avandia and, therefore, was considered a safer alternative. Doctors switched their patients to Actos in droves, and the fortunes of Takeda’s type 2 diabetes drugs improved almost overnight.
There was no reference to the potential for Actos and bladder cancer at the time.
There is now, on both sides of the border and for that matter, around the world: in June of 2011, regulators in France and Germany pressured Takeda to remove Actos from availability in the two countries. The European Medicines Agency and the FDA have allowed sales to continue amidst warnings. Health Canada adopted a similar stance, noting that it was content to allow sales to continue given product material that already referenced the possibility for Actos bladder cancer that had been reported only rarely.
Tell that to Nancy Rios, who was 54 at the time she was pursuing an Actos lawsuit against Takeda and blaming her recurring bladder cancer on the drug. The CBC reported through AP at the time that Rios, who lived in Reading, Pennsylvania, noted that she had used Actos for more than a decade. The hospital secretary was diagnosed with Actos bladder cancer in 2009, and in June 2011, had undergone a second procedure to remove tumors from her bladder.
“I could lose my bladder and possibly need chemo,” she told AP at the time.
Over the last few years, as Actos side effects associated with the bladder have become increasingly prevalent in the mindset of the type 2 diabetes nation, sales of Actos have fallen off. However, following the Avandia scare in 2007, sales of Actos jumped from $2.9 billion in 2006 to more than $4.3 billion in the United States by 2010.
Meanwhile, Eli Lilly and Company revealed in its Form 10-K filing with the US Securities and Exchange Commission (SEC) for the fiscal year ending December 31, 2015 that Lilly is named along with Takeda Chemical Industries Ltd. in no fewer than four class-action lawsuits in Canada.
Two are in Ontario (Casseres et al. v. Takeda Pharmaceutical North America, Inc., et al.; and Carrier et al v. Eli Lilly et al.), one in Quebec (Whyte et al. v. Eli Lilly et al) and one in Alberta (Epp v. Takeda Canada et al).
Lilly marketed Actos in Canada until 2009. Thus, Lilly has an alleged liability in Actos side effects lawsuits in Canada.
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