Consumer Reports Warns About Actos Side Effects

Boston, MAAt least one consumer group is warning patients that the risk of Actos side effects might not outweigh the benefits. Consumer Reports, concerned about the potential link between Actos and bladder cancer, and Actos and heart failure, has warned patients that Actos should not be considered a first-line treatment for type 2 diabetes.

In an article in Consumer News (08/21/12), Consumer Reports recommends patients with type 2 diabetes avoid Actos—both brand name and generic—unless other medication options have not worked.

"Pioglitazone can cause serious side effects, such as an increased risk of heart failure, bone fractures, and bladder cancer," the organization advised. "Other medications to treat diabetes, such as metformin, are a better first choice." The warning came after the US Food and Drug Administration (FDA) approved generic versions of Actos for the market. Consumer Reports, however, not only suggested patients try different medication before Actos, they recommended using Actos, "only as a last resort."

Studies suggest Actos is linked to an increased risk of bladder cancer in patients with type 2 diabetes, a group of patients who are reportedly already at an increased risk of the disease. A study published in the Canadian Medical Association Journal (07/03/12), notes that patients who have type 2 diabetes have a 40 percent increased risk of bladder cancer, but that risk could be further increased by the use of thiazolidinediones (a group of drug that includes Actos).

Researchers analyzed biomedical databases for information on the link between pioglitazone (the generic form of Actos) and other drugs in the class with bladder cancer. They found patients who used thiazolidinediones—especially Actos—were at an increased risk of bladder cancer, even above the risk faced by those with type 2 diabetes.

"Although the absolute risk of bladder cancer associated with pioglitazone was small, other evidence-based treatments for type 2 diabetes may be equally effective and not carry a risk of cancer," the authors wrote.

In 2011, the FDA issued a warning that Actos may be linked to an increased risk of bladder cancer. On August 4, 2011, the FDA announced updated warning labels for drugs that contain pioglitazone to include information that use of the drug for more than one year may be associated with an increased risk of bladder cancer. Lawsuits have since been filed alleging Takeda Pharmaceuticals, maker of Actos, failed to properly warn patients about the risk of bladder cancer associated with Actos.