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Study Confirms Actos, Other Thiazolidinediones Increase Bladder Cancer Risk

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A new study confirms that Actos and other thiazolidinediones drugs do, in fact, increase the risk for developing bladder cancer. The study appears online this month in the Journal of the National Cancer Institute.

Researchers from the Perelman School of Medicine at the University of Pennsylvania discovered that patients taking Actos and other thiazolidinedione (TZDs) drugs suffer a two-to-three-fold increased likelihood of developing bladder cancer when compared to people who took a sulfonylurea drug, said Science Daily. TZDs comprise some 20 percent of medications prescribed to diabetics in the United States; sulfonylurias are another popular diabetes drug class that include Glucotrol (glipizide).

The study authors wrote that the findings are significant given that diabetics are at a slightly increased risk for bladder cancer, versus the general population, said Science Daily, which noted that about 30 in 100,000 people develop the cancer. In diabetic patients the risk is about 40 in 100,000.

For their study, the researchers analyzed 60,000 Type 2 diabetes patients from the United Kingdom’s Health Improvement Network (THIN) database, said Science Daily. The team found that patients treated with the TZDs Actos (pioglitazone) or Avandia (rosiglitzaone) for at least five years experienced a two-to-three-fold increased risk for developing bladder cancer, versus patients taking sulfonylurias. In fact, the team found that 170 per 100,000 patients taking TZDs for at least five years would likely develop bladder cancer versus 60 per 100,000 sulfonylurea patients, said Science Daily.

“Diabetes is one the most common chronic diseases worldwide, affecting 285 million people. There are many factors clinicians must weigh in deciding which drug to use to control a patient’s diabetes, and these new data provide important information to include in that decision-making process,” study lead, Ronac Mamtani, MD, an instructor in the division of Hematology-Oncology in Penn’s Abramson Cancer Center, told Science Daily. “Our study shows that doctors who care for patients with diabetes should be very aware of any bladder-related symptoms patients might be having, like blood in the urine, and take steps to further evaluate those issues,” Mamtani added.

Since November 2007, Avandia’s U.S. label has included a black box warning over its heart attack links. In 2010, the FDA placed severe restrictions on Avandia sales after it found that the drug’s heart risks outweighed its benefits. To date, more than 2,500 Avandia lawsuits have been consolidated before U.S. District Judge Cynthia Rufe in Avandia Marketing, Sales Practices and Products Liability Litigation (MDL No. 01871), U.S. District Court, Eastern District of Pennsylvania, Philadelphia. Actos is the ninth most commonly prescribed drug in the U.S., which translates to about 15 million prescriptions annually, noted Science Daily.

In addition to prior FDA warnings about Actos and other TZDs’ links to bladder cancer, France and Germany have taken the drug off their markets, Science Daily pointed out. “The risk does seem to be common among both drugs in the TZD class, and the fact that we have compared bladder cancer risk among patients taking each of those drugs provides essential information, because a safety warning on a drug is only useful to a doctor when they have knowledge of the same risks for an alternative drug,” Mamtani told Science Daily. “We believe our study will help doctors and their patients weigh the potential benefits and risks when selecting between different diabetes medication.”

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