Actos Removed from Market in India Amid Bladder Cancer Risk

Following mounting concerns worldwide over the risk of heart failure and bladder cancer from Actos, India became the latest country to ban the popular diabetes drug last month.

The Indian Ministry of Health and Family Welfare decided to remove Actos from the market, impacting any medications that contain the active pharmaceutical ingredient pioglitazone. Actos has already been recalled in France and Germany, and a black box warning is on the drug’s label in the United States.

Over the past few years, a number of studies have raised concerns about the link between Actos and bladder cancer following long-term use of the medication. Indian health officials also indicated that previous concerns about an increased risk of heart failure associated with the diabetes drug was considered in the decision for Actos to be removed from the market.

Actos (pioglitazone) was approved in the United States in July 1999, as a once-daily pill for treatment of type 2 diabetes. The medication increases the body’s sensitivity to insulin, but many have question whether the medication provides sufficient benefits compared to other available diabetes treatments to justify the risk of Actos side effects.

Actos Bladder Cancer Risk

In the United States, the FDA announced that it was examining the bladder cancer risk associated with Actos in September 2010, after preliminary data from an on-going study indicated that users may face an increased risk of tumors when the medication is taken for more than a year.

Following a review of public insurance data in France, sales of Actos were suspended in France and Germany in June 2011.

That same month, the FDA announced that new warnings about the Actos bladder cancer risk would be added to the warning label.

Over the past two years, several additional studies have further confirmed the link between Actos and cancer. A June 2012 study published in the British Medical Journal found that Actos may double the risk of bladder cancer after two years, and another study presented at the American Society of Clinical Oncology’s annual meeting in May 2012 suggested that the risk may apply to all drugs belonging to the same class of medications, known as thiazolidinediones, which also includes Avandia and Rezulin.

A study published in the Journal of the National Cancer Institute in August 2012 found that Actos users may face triple the risk of cancer when the medication is used for longer than five years.

U.S. Actos Bladder Cancer Lawsuits

Takeda Pharmaceuticals faces thousands of Actos bladder cancer lawsuits in courts throughout the United States, which have been filed by patients who allege that the drug maker failed to adequately warn the medical community or patients about the drug’s side effects.

More than 1,500 federal complaints filed in U.S. District Courts throughout the country have been consolidated for pretrial proceedings as part of an Actos MDL, or multidistrict litigation. The cases have been centralized before U.S. District Judge Rebecca Doherty in the Western District of Louisiana. A number of claims have also been filed at the state level.

Earlier this year, the first trial in the country was held in California state court involving a man who developed bladder cancer in November 2011, following two years of Actos use. That case was given an expedited trial date under California procedural rules, due to his grave health condition.

Following more than two months of trial, a Los Angeles jury awarded $6.5 million in damages in the Actos case, finding that Takeda Pharmaceuticals failed to adequately warn about the potential side effects of their blockbuster diabetes drug. However, the judge who presided over the trial subsequently overturned the damage award after excluding key expert witness testimony offered at trial to establish that side effects of Actos were the cause of this specific plaintiff’s bladder cancer diagnosis.

Additional cases are scheduled to begin in federal court in January 2014 and April 2014, serving as “bellwether” trials to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout a number of lawsuits. The outcomes of these early trials may influence negotiations to settle Actos cases nationwide.