Actos is the brand name of the drug pioglitazone, used to treat type 2 diabetes, and the U.S. Food and Drug Administration (FDA) has just released a new warning that it could cause bladder cancer. This is not the first time the FDA has made this warning about pioglitazone, but the latest report comes as an update after more extensive reviews. The FDA is urging doctors and patients to be aware of this risk and to balance it against the possible benefits of using Actos.

Actos and Type 2 Diabetes

Type 2 diabetes is a chronic condition in which the body no longer responds well to insulin, the hormone released by the pancreas and that controls blood sugar levels. The result is high blood sugar levels, which if not controlled can lead to a number of serious complications ranging from heart disease to nerve damage and kidney failure.

Drugs like pioglitazone are designed to lower blood sugar and to be used along with changes in diet and exercise. Unfortunately, while these drugs do lower blood sugar levels, they come with a number of side effects and even more serious potential risks. Pioglitazone controls blood sugar by increasing the body’s sensitivity to insulin, but it can also cause headaches, infections, muscle pains, can worsen congestive heart failure, and increase the risk of developing bladder cancer.

Bladder Cancer

Takeda, the pharmaceutical company responsible for Actos, got FDA approval for this drug in 1999. It was not until more than ten years later that the risk of bladder cancer was discovered. In lawsuits over this risk, emails dating back to 2005 were discovered that indicated the company knew about the risk but did not communicate it to the FDA, doctors, or the public.

In 2010 the FDA issued its first warning about bladder cancer with Actos and required that Takeda change the drug’s label to include this risk. The FDA also required that Takeda continue with a ten-year study that first brought the issue of bladder cancer to the agency’s attention. The latest warning comes as the result of updated information from this study which confirms that the risk of bladder cancer is significant. The FDA is requiring more updates to the pioglitazone labels to describe the updated study results.

FDA Recommendations

With the latest warning about bladder cancer and pioglitazone, the FDA has made several recommendations, although it is stopping short of recalling the drug. The FDA recommends to doctors that Actos not be prescribed to anyone with bladder cancer and that its benefits and risks should be carefully weighed for anyone with a history of this cancer or with other risk factors for it.

The FDA also recommends that patients taking pioglitazone be aware of the risk of bladder cancer and tell their doctors if they experience any warning symptoms: blood in the urine, pain during urination, and increasing urges to urinate.

The risk of developing bladder cancer while on pioglitazone is small but significant. All patients with type 2 diabetes need to be aware of the risks of these medications and understand that they have a right to be informed. If you have developed a condition as the result of taking this medication, such as bladder cancer, you may be able to file a successful lawsuit to recover compensation.