Actos And Bladder Cancer: Risks, Warnings, & Information

Although Actos first hit the prescription drug market in 1999, there is mounting evidence of a link between Actos and bladder cancer. Since 2007, it has been the most commonly prescribed drug in the world for treating type 2 Diabetes. In 2010, it was prescribed more than 2.3 million times, making it the 10th-most prescribed drug in the United States, producing nearly $5 billion in sales per year. That represents approximately 27 percent of the annual revenue for its parent company Takeda Pharmaceuticals.

Several recent studies have shown a much stronger link between Actos and bladder cancer than was indicated during clinical trials. In June 2011, the U.S. Food and Drug Administration (FDA) published a “Drug Safety Communication,” indicating that based on dose and duration of use, there exists a 40 percent increased risk associated with taking Actos and developing bladder cancer.

Bladder cancer is an aggressive and potentially fatal disease. If you were prescribed Actos and then later developed bladder cancer you may be eligible for compensation. To get more information about Actos bladder cancer or about seeking compensation for your pain and suffering, fill out the form below or call 1-800-452-0949.

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Although the FDA required an update to the drug’s label in the “Warnings and Precautions” section of the drug’s insert to reflect the increased risk, Actos remains on the market unrestricted. Prior to the FDA’s announcement a few lawsuits had been filed, against Takeda, alleging Actos caused bladder cancer. Since then, however, there has been a large increase in Actos bladder cancer lawsuits filed.

Studies Linking Actos And Bladder Cancer

Three primary studies are most cited regarding Actos bladder cancer. The foremost is a 10-year study conducted by Kaiser Permanente Northern California. Sponsored by Takeda and required by the FDA, it started in 2002 after preclinical trials indicated an increase in urinary bladder tumors in rats. Although the study is not yet complete, a five-year interim analysis indicated a 40 percent increased risk of bladder cancer in patients who took Actos for more than 12 months. That analysis is the basis for the FDA’s label and insert requirements regarding Actos bladder cancer. The study also found that men taking Actos were more likely to develop bladder cancer than women.

The most widely known international study, researching Actos bladder cancer, is a three-year study by the French Medicines Agency from 2006 to 2009 that examined 1.5 million patients. It found a statistically significant indication that patients taking pioglitazone, the active ingredient in Actos, are at a greater risk of developing bladder cancer. Researchers stated their findings were very similar to those of the KPNC study.

In June 2011, the French Medicines Agency announced that it had suspended the use of Actos. Germany quickly followed suit, except it limited suspension to all new cases. In August 2011, Takeda formally withdrew Actos from those markets. In April 2011, The American Diabetes Association published a report that reviewed adverse drug reports filed with the FDA. Researchers stated they “found a definite signal for bladder cancer associated with pioglitazone use.”

FDA Warnings About Actos Bladder Cancer

Prompted by an interim report covering the data produced by the Kaiser Permanente study, the FDA in September 2010 announced a safety review of Actos as a treatment of type 2 diabetes. Nine months later, in June 2011, the FDA declared there was a statistically significant relationship between Actos and bladder cancer and that the link deserved more investigation. In August 2011, the FDA approved an update to the Actos warning label to publicize the possible link between extended use of Actos (12 months or more) and an increased risk of developing bladder cancer.

Unlike other warnings about severe side effects, the update is to the warnings and precautions section and not to contraindication section. There will not be an update to the drug’s black box label indicating the risks of Actos bladder cancer. Although the FDA recognizes the statistical significance, it has not come to a definitive conclusion about the link between the two.

What Causes Bladder Cancer

Bladder cancer is the fourth-most common cancer afflicting Americans. Nearly 67,000 new cases are diagnosed every year. An insidious disease, bladder cancer is often recurrent, and the five-year survival rate for advanced stage bladder cancer is less than 50 percent, with approximately 14,000 people falling victim to it every year. It is thought that bladder cancer is caused when normal cells in the urinary bladder form masses. Called growths, or tumors, these masses can start with a seemingly innocuous symptom, such as blood in the urine, painful or frequent urination or straining during urination. Other common symptoms associated with bladder cancer include fatigue, incontinence, weight loss and bone pain or tenderness. Sometimes the first symptoms of bladder cancer are not apparent until the disease is in its most advanced – and deadly – stage, called metastatic bladder cancer.

Some people consider the evidence linking extended Actos use to bladder cancer strong because the normal risk factors of developing bladder cancer are: long-term exposure to certain industrial chemicals found in certain industries, smoking, previous cancer treatment or a history of cancer. The medical theory about bladder cancer is that it is caused by an increased concentration of toxic chemicals in urine, which in turn exposes the bladder to those same chemicals. And that, over time, this exposure causes cancer. Bladder cancer is described as a signature disease of Actos, pointing to the theory of toxic exposure being a primary cause of the disease.

Actos Bladder Cancer Lawsuits

It is estimated that Takeda could face more than 10,000 Actos bladder cancer lawsuits. In recent court filings, Takeda admitted it already is being sued in federal court because of Actos bladder cancer. With the June 2011 announcement by the FDA that it was requiring a bladder cancer warning placed on the Actos label and insert, the FDA gave legitimacy to many former Actos users’ claims that the drug caused them to develop bladder cancer.

Those claims had received limited response from the courts, Takeda, and the FDA. Since the FDA announcement, there has been a marked increase in the filing of Actos lawsuits and also in inquiries about the possibility of filing a lawsuit. With several hundred cases pending, both Takeda and plaintiff attorneys filed to move all pending Actos lawsuits to one district court. On Dec. 30, 2011 the U.S. Judicial Panel on Multidistrict Litigation in Georgia consolidated all federal Actos bladder cancer lawsuits to the U.S. District Court for the Western District of Louisiana.