Health Canada Knows All About Potential for Actos and Bladder Cancer

Ottawa, ONThe caseload in the Actos bladder cancer multi-district litigation continues to swell as Actos side effects lawsuits such as that filed by plaintiffs Matthew Gasparovic and Sumico Yamana are brought into the fold. In the meantime, we’re just beyond the 5-year anniversary of an investigation into Actos and bladder cancer by the Canadian equivalent of the US Food and Drug Administration (FDA), Health Canada.

The latter announced on June 17, 2011 its intention to undertake a safety review of Actos (pioglitazone). “In light of studies suggesting an increased risk of bladder cancer with the diabetes drug pioglitazone, as well as actions taken by other regulatory agencies, Health Canada is informing healthcare professionals and Canadians that it is undertaking a review of the drug's status,” the release stated.

“Should the on-going review identify new safety information, Health Canada will take appropriate action as necessary. This can include updating Canadians with new recommendations regarding pioglitazone and the potential risk,” for Actos bladder cancer.

Less than a year later that investigation was complete. On April 16, 2012 Health Canada alerted doctors and healthcare professionals as to the real, albeit rare potential for Actos and bladder cancer in association with the use of pioglitazone.

“Findings from new studies reveal that there is a potential increased risk of bladder cancer in patients treated with pioglitazone-containing products,” Health Canada stated. Most telling in the Health Canada release was reference to a fifth-year interim report of an ongoing ten-year observational cohort study in patients with diabetes.

“Interim results from this study suggested that taking pioglitazone longer than 12 months increased the relative risk of developing bladder cancer in any given year by 40 per cent, which equates to an absolute increase of three cases in 10,000 from approximately seven in 10,000 (without pioglitazone) to approximately 10 in 10,000 (with pioglitazone).”

Meanwhile, in the US the Gasparovic Actos lawsuit has been transferred to Cook County Court from its original jurisdiction governed by the Illinois Supreme Court, for consolidation in Actos multidistrict litigation for pre-trial discovery.

Gasparovic alleges that his use of Actos for ongoing treatment of Type 2 diabetes exposed him to Actos bladder cancer. The defendants in the Actos bladder cancer lawsuit, filed in March of this year, are Takeda Pharmaceuticals, Walgreens and Eli Lilly. Gasparovic seeks compensation for medical expenses, bodily damage, pain and suffering, anxiety and mental anguish, disability and the loss of a normal life.

The Actos lawsuit is Gasparovic v. Takeda Pharmaceuticals et al, Case No. 16-L-300.