Takeda’s Type2 Diabetes drug, Actos (pioglitazone) has been the subject of FDA warnings as a result of its link to an increased risk of bladder cancer amongst patients who use the drug the longest. On June 17, 2011, two days after the FDA issued their warning, Health Canada issued a similar warning.
On April 19, 2012 Health Canada followed their previous warning with a change in labeling to indicate the link to bladder cancer.
It now appears that the Ontario Public Drug (OPD) Program has taken the additional step of limiting patient access to Actos.
The ODB Program provides coverage for over 3,800 drug products that are listed in the ODB Index or formulary. If a drug is not listed in the ODB formulary, patients are required to submit a request for the unlisted drug which then becomes part of the Exceptional Access Program (EAP) and the Executive Officer makes decisions regarding its funding on a case by case basis. Effective April 24, 2012, Actos has been moved to the “exceptional access” list. This change comes at the midway point of Takeda’s 10-year study which Health Canada believes to be pointing to a real link between Actos and bladder cancer.
According to Dr. David Jurlink, head of the division of clinical pharmacology at the University of Toronto:
At this point there is little need to resort to this drug, unless a patient has done extraordinarily well on it in the past. I personally would not be comfortable using it as a long-term therapy because bladder cancer is…not something that’s reversible. Its not a skin rash that goes away when you stop the drug.
Takeda is already facing hundreds of lawsuits as a result of its link to bladder cancer and the possibility that their RE-LY trials downplayed reports of bladder cancer and congestive heart failure.
TorHoerman Law is very proud to be named as a leader in the national Actos litigation in front of Judge Deborah Dooling in Cook County. All Actos cases in the country are able to be filed in Cook County. If you have any questions about filing your Actos cases in Cook County, please contact us directly.
Sources: The Canadian Press, Consumer Justice Foundation