Actos and Bladder Cancer

Diabetics who had been prescribed Actos recently discovered that use of this medication, for a year or more, has put them at increased risk for developing bladder cancer. Some studies indicate that the increased risk can be as much as a 40%. The European studies resulted in regulators in Germany and France ordering doctors to stop prescribing the drug. Patients who had the lengthiest exposure to and the highest cumulative dose of Actos are at greater risk.

For those unfamiliar with the drug, Actos (pioglitazone) is a prescription medication that was approved by the FDA to be used as a treatment for Type II diabetes. Actos works by increasing the body’s sensitivity to insulin. It has been a popular choice of health-care providers in the US.

The FDA recently issued a safety announcement about use of the drug. Based on the preliminary results of a 10-year study, which was begun by Takeda Pharmaceutical Company (manufacturer of Actos), which were reviewed by the FDA, a safety announcement was made on June 15, 2011. The announcement warned that, "use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer."

Recently, allegations have been raised over Actos and what the drug company Takeda knew about the link between Actos and bladder cancer. It is being alleged that Takeda had a significant financial incentive to conceal the potential dangers associated with long term use of Actos.

Patients who are on Actos are advised to seek the advice of their physicians immediately and continue taking all medications until they do so. Discontinuing diabetes medications without guidance can result in serious short-term health problems and increased risk of diabetes-related complications.

Bladder cancer is often asymptomatic until it is in an advanced stage so it is important for patients who are at higher risk to be especially vigilant. As a patient having taken Actos how do you determine if you have bladder cancer? Most common symptoms include:

  • The first and most common symptom of bladder cancer is blood clots or blood in the urine. This can be microscopic and not visible to the naked eye. It is detectable with a simple urine test. Usually there is no pain. It is also possible that the urine will have a slightly pink, orange or bright red color with or without clots.
  • Pain or a burning sensation during urination without evidence of a urinary tract infection.
  • Getting frequent urinary tract infections
  • A change in urination patterns such as urinating more frequently, a sense of urgency while urinating in small amounts.
  • As the disease progresses, the patient may experience lower back pain, swelling in the lower legs and even a pelvic mass.
  • As the cancer spreads, the patient may experience weight loss, anemia and/or bone pain in the rectal or pelvic areas.

While having these symptoms does not necessarily indicate bladder cancer, you should see your health-care provider immediately if you experience any of these symptoms.

It is also possible to have no symptoms until the bladder cancer reaches an advanced state. Therefore, it you have been on Actos and feel you are at increased risk, ask your health-care provider about screening tests.