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Following several thousand lawsuits and a multi-billion dollar settlement paid by the drug maker for failure to adequately warn about the potential side effects of Actos, a new study provides further confirmation that the controversial diabetes drug may significantly increase the risk of bladder cancer.
Actos (pioglitazone) was one of the most widely used type 2 diabetes drugs in the United States until about 2010, when concerns emerged about the potential link between Actos and bladder cancer.
About 8,000 Actos lawsuits were filed against Takeda Pharmaceuticals by individuals who indicated they developed bladder cancer following use of the medication. While the drug maker has attempted to defend the safety of their diabetes treatment, a $2.4 billion Actos settlment was reached in April 2015, following several multi-million dollar jury awards returned in individual cases that went to trial.
The findings of a study published by the medical journal The BMJ on March 31 appear to confirm the findings of prior research, which Takeda had attempted to challenge at trial.
Researchers from the Centre for Clinical Epidemiology at the Lady Davis Institute in Jewish General Hospital in Montreal, conducted a population-based cohort study which looked at data on more than 145,000 patients. The subjects were newly treated with an antidiabetic drug between January 1, 2000 and July 31, 2014.
The study found that that the use of Actos was associated with a 63% increased risk of bladder cancer. Researchers also discovered that a similar diabetes drug, Avandia (rosiglitazone), which belongs to the same class of medications known as thiazolidinediones, was not associated with a similar increased risk.
“The results of this large population based study indicate that pioglitazone is associated with an increased risk of bladder cancer,” the researchers concluded. “The absence of an association with rosiglitazone suggests that the increased risk is drug specific and not a class effect.”
In June 2011, the FDA required Takeda Pharmaceuticals to update the Actos warning label to add information about the bladder cancer risk, informing consumers that they may face an increased risk the longer the drug is used.
According to allegations raised in bladder cancer lawsuits filed in courts throughout the U.S., Takeda actively withheld information from consumers and the medical community.
In April 2014, a federal jury awarded $9 billion in punitive damages designed to punish the drug maker, after evidence was presented that suggested Takeda destroyed evidence about the risk of bladder cancer faced by users. While the U.S. District Judge presiding over the litigation later reduced the punitive damages to $37 million, she indicated that the Supremen Court needs to update rules on what is considered excessive in order to effectively deter large corporations from engaging in the type of bad behavior exhibited by the makers of Actos.
While the FDA has not required an Actos recall, sales of the drug have fallen substantially since information has become available to consumers and doctors about the potential bladder cancer risk.