Update: FDA Confirms Actos Bladder Cancer Link
December 15, 2016 – FDA has updated its review of Actos, confirming that use of the drug may increase the risk of bladder cancer. While Actos labels already contain a warning about the bladder cancer risk, the agency is once again updating the labeling to describe the additional studies it has reviewed.
What is Actos?
Actos (pioglitazone) is an oral anti-diabetic medication in the thiazolidinedione class. It works by improving how the body uses insulin and decreasing the amount of glucose (sugar) released by the liver. Since it was released in 1999, Actos has generated more than $16 billion in sales for Japanese drug-maker Takeda Pharmaceuticals.
In December 2011, federal judges centralized Actos lawsuits into a Multi-District Litigation (MDL No. 2299) in the U.S. District Court for the Western District of Louisiana, before Judge Rebecca F. Doherty:
Plaintiffs in the litigation make similar legal claims against Takeda Pharmaceuticals, namely:
“Plaintiffs allege that individuals who use Actos face an increased risk of developing bladder cancer. Plaintiffs further allege that the defendants concealed their knowledge of this risk and failed to provide adequate warnings to consumers and the health care community.”
FDA Warning: Actos Bladder Cancer Risk 40% Higher
In June 2011, the U.S. Food and Drug Administration (FDA) published a Drug Safety Communication to warn that using Actos for more than one year was associated with a 40% increased risk of bladder cancer compared to patients who never took Actos.
Studies of Actos and Bladder Cancer
In 2011, Actos was pulled off the market by health authorities in France and Germany after a study involving 1.5 million people with diabetes linked Actos to an increased risk of bladder cancer, particularly in men who took higher doses for a longer time.
More recently, a study published in the British Medical Journal in May 2012 found that the rate of bladder cancer doubled for people who took Actos for more than two years, and the risk increased with cumulative dosage.
Las Vegas Widow Blames Husband’s Bladder Cancer Death on Actos
78-year-old Mary Iorio was widowed in November 2013 when her husband Maurice, an Actos user, died after having surgery to remove his bladder. Mary believes Actos was the cause of her husband’s bladder cancer, and is suing Takeda for failing to warn of the risk. Click here to learn more.
What is Bladder Cancer?
Bladder cancer is relatively uncommon in the United States, with about 72,500 new cases reported in 2013, and 15,200 deaths. Most bladder cancers occur when cells begin dividing out of control in the epithelial lining of the urinary bladder. More than 90% of bladder cancers occur in transitional cells, which stretch when the bladder is full and shrink when it’s emptied. Other types include squamous cell carcinoma and adenocarcinoma, which develop in the inner lining of the bladder as a result of chronic inflammation and irritation.
Symptoms of Bladder Cancer
- Blood or red color in urine
- Urgent need to urinate
- Pain when urinating
- Needing to strain to empty the bladder
- Pain in back or lower abdomen
- Swelling of the legs
- Unexplained weight loss
Actos Use Linked to 40% Increased Risk of Pancreatic Cancer
A study published in the July 21, 2015 edition of the Journal of the American Medical Association (JAMA) found that Actos use was associated with a 40% increased risk of pancreatic cancer, a largely incurable disease with a poor survival rate. Conclusions were based on data compiled since 1997 on about 236,000 diabetes patients over the age of 40 who used Actos to treat their symptoms. Click here to learn more.
Actos and Prostate Cancer
The JAMA study cited above also identified a link between Actos use and a 13% increased risk of prostate cancer, the second leading cause of cancer death in American men. While the FDA has not yet issued a warning about prostate cancer or pancreatic cancer associated with Actos, the study’s authors believe their conclusions were concerning enough to warrant further investigation.
“The increased prostate and pancreatic cancer risks associated with ever use of pioglitazone merit further investigation to assess whether they are causal or are due to chance, residual confounding, or reverse causality,” the researchers concluded. Click here to learn more.
$2.37 Billion Actos Settlement Finalized
September 15, 2015 – Takeda now has 96% of claimants on board with its offer to settle thousands of lawsuits alleging Actos caused bladder cancer for $2.37 billion, according to FiercePharma. If 97% of the claims meet the settlement criteria, Takeda has agreed to up the payout by $100 million, for a grand total of $2.4 billion.
Actos Settlement on Shaky Ground as Deadline Nears
Takeda’s proposed settlement of more than 10,000 Actos bladder cancer lawsuits didn’t attract enough participants by the August 12, 2015 deadline to move forward, raising doubts about whether the $2.37 billion deal will survive. The drugmaker is obligated to fund the settlement after 95% of plaintiffs join it, according to Bloomberg News. However, by August 12 only about 75% had agreed to the deal, so the deadline was pushed back to September 11.
Do I have an Actos Class Action Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Actos Lawsuit Evaluation: Again, if you or a loved one was injured by Actos, you should contact our law firm immediately. You may be entitled to compensation by filing an Actos lawsuit, and our lawyers can help.