Actos Bladder Cancer - Diabetes Drug Risk, FDA Warning

Actos Bladder Cancer

Diabetes Drug Risk, FDA WarningBladder cancer is one of the most concerning side effects associated with type II diabetes drug Actos. Since it was introduced to the U.S. market by Takeda Pharmaceuticals in 1999, reports of serious side effects, including an increased risk of bladder cancer, have caught the attention of the FDA and regulatory agencies across the globe. Although multiple studies have provided evidence that long-term use of Actos increases the risk of bladder cancer—and despite the fact that the drug has been removed from several European markets— Actos continues to be sold in the United States.

Even before the drug was released in the U.S., early trials conducted on rats suggested a link between Actos use and the formation of malignant tumors in the bladder. Despite these findings, Takeda moved forward with their aim of getting approval to market their drug in the United States. Though the company has been accused of failing to warn healthcare providers and the general public about the potential risks of the drug, subsequent studies have increased awareness about concerns regarding Actos.

In 2002, the FDA launched a 10-year epidemiological study of the risks associated with the drug. In 2011, the agency issued a safety communication that indicated there could be a 40% increased risk of bladder cancer for Actos users. Results of studies recently published in the British Medical Journal suggest that risk might even be as high as 83% in some cases.

Studies support Actos bladder cancer risk

A French study conducted from 2006 to 2009 found a higher risk of bladder cancer among Actos users. Researchers looked at 155,000 type II diabetes patients taking Actos and another 1.3 million diabetics who were not prescribed the drug. They found the risk of bladder cancer increased with Actos use, particularly among patients on higher doses of the drug. The study prompted the suspension of Actos sales in both France and Germany soon after results were reported.

Also in 2011, the American Diabetes Association published a report from the FDA involving the link between Actos use and bladder cancer. The report concluded there was an association between the two, with a higher risk of bladder cancer in diabetes patients that took Actos for two years or more. That same year, the FDA issued their safety communication, warning about the 40% increased risk of bladder cancer among Actos users. Their warning was based on a five-year analysis of more than 193,000 diabetes patients that took Actos for a minimum of two years.

In 2012, a Canadian study also confirmed an increased risk of bladder cancer for Actos users. Researchers in this study analyzed data on 115,000 diabetes patients treated with diabetes drugs between 1988 to 2009. They found that use of Actos for two years or more doubles a person’s risk for developing bladder cancer. A second Canadian study that same year yielded similar results, although their findings suggested a 22% increase in bladder cancer risk.

About bladder cancer

Bladder cancer is a cancer that typically begins in the cells that line the inside of the bladder. If it is discovered in the early stages, the prognosis is very good. However, there is a high incidence of recurrence with bladder cancer, which means patients will need to undergo regular monitoring and possibly additional treatment after the initial diagnosis is addressed.

Risk factors for bladder cancer

In addition to long-term Actos use, other risk factors for bladder cancer include:

  • Gender (males are more likely to be diagnosed)
  • Smoking
  • Increasing age
  • Heredity
  • Race (whites are more likely to be diagnosed)
  • Exposure to toxic chemicals
  • Chronic bladder inflammation

Symptoms of bladder cancer

Bladder cancer may be accompanied by the following symptoms:

  • Frequent or painful urination
  • Blood in the urine
  • Back or pelvic pain
  • Recurring bladder infections
  • Unexplained weight loss


Bladder cancer may be diagnosed through various procedures that allow the physician to look inside the bladder, including cystoscopy and imaging tests. A sample of a tumor may also be collected for a biopsy.

Once bladder cancer is diagnosed, treatment may include the following:

  • Chemotherapy shrinks the tumor and slows down progression of the disease
  • Immunotherapy signals the body’s own immune system to destroy cancer cells
  • Transurethral resection removes the tumor through cauterization
  • Segmental cystectomy removes the tumor and the diseased portion of the bladder
  • Radical cystectomy removes the entire bladder and creates a urinary diversion

The link between Actos and bladder cancer

No one is sure exactly how Actos use may lead to bladder cancer. Actos works to treat diabetes by making the body more sensitive to insulin. Since cancer cells can use insulin to grow, this process may play a role in the increased risk. Scientists have also surmised that Actos use can result the formation of crystals that irritate the bladder and could lead to cancer. Although the cause and effect relationship between Actos and bladder cancer is not clear at this time, there is evidence from multiple studies showing an association between the two.

Filing an Actos lawsuit

As more evidence is documented linking Actos and cancer, those who have been injured by the drug may have the option of filing an injury lawsuit. Some involved in the legal proceedings estimate there could be as many as 10,000 complaints filed against Takeda in courtrooms across the country before the litigation resolves.

Federal Actos lawsuits filed against Takeda have been coordinated into multidistrict litigation (MDL) in U.S. District Court for the Western District of Louisiana. The honorable Judge Rebecca F. Doherty is presiding over the MDL, which was established to streamline early trial proceedings for cases with similar complaints against Takeda. State-level complaints have also been coordinated in Los Angeles, California.

Plaintiffs who have filed an Actos lawsuit allege the drug led to their cancer diagnosis. They have also stated in their complaints that Takeda failed to warn the medical community and general public about the risks, despite early clinical trials that suggested an association between Actos use and a higher bladder cancer risk.

  1. Mayo Clinic, Bladder Cancer,

  2. FDA, FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer,

  3. United States District Court, Western District of Louisiana, MDL No. 2299,

  4. WebMD, Diabetes Drug Actos Again Linked to Cancer,

  5. U.S. News and World Report, Another Study Links Diabetes Drug Actos to Bladder Cancer,

  6. MedPage Today, Study Affirms Actos Bladder Cancer Risk,

  7. MedPage Today, Cancer Risk Forces Actos off French, German Markets,

  8. Diabetes Journals, Risk of Bladder Cancer among Diabetic Patients Treated with Pioglitizone,