Actos Bladder Cancer Warnings Updated by FDA to Add New Study Data Reviewed

Years after federal drug regulators first indicated that diabetics may face an increased risk of bladder cancer from Actos, new information will be added to the drug warning label about additional studies and evidence reviewed.

The FDA issued an drug safety communication on December 12, indicating that all diabetes drugs containing the active ingredient pioglitazone will carry additional information about the potential bladder cancer risk, including Actos, Actoplus Met, Actoplus Met XR, Duetact and Oseni.

The updated label warnings comes after thousands of Actos bladder cancer lawsuits were brought by individuals nationwide, each alleging that the manufacturer withheld information from consumers and the medical community for years. and a multi-billion dollar settlement. Following lengthy litigation, Takeda Pharmaceuticals ultimately agreed to pay nearly $2.4 billion to resolve more than 8,000 cases last year.

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.

“As a result of an updated review, the U.S. Food and Drug Administration (FDA) has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer,” the new drug safety communication issued this week warns. “The labels of pioglitazone-containing medicines already contain warnings about this risk, and we have now approved label updates to describe the additional studies we reviewed.”

The FDA found that results varied among a number of studies conducted since its first Actos bladder cancer warning in 2011. However, the FDA determined that, overall, the evidence still appears to show a link between use of the drug and bladder cancer risk.

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 Supreme 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.