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The U.S. Food and Drug Administration (FDA) has issued two warnings about the safety of Actos.

FDA Warnings about Actos®

Actos (the generic name is pioglitazone hydrochloride) was approved by the FDA in July 1999. Since its approval, the FDA has required the drug’s maker, Takeda Pharmaceuticals, to add two boxed warnings to the medication label:

  • One warning concerns an increased risk for heart failure
  • The other warning is about an increased risk of bladder cancer.

FDA Warning: Actos® and Congestive Heart Failure

Actos is in a class of drugs called thiazolidinediones, which are prescribed along with a controlled diet and exercise for persons with type 2 diabetes to improve their levels of blood sugar. In August 2007, the agency added a new warning to the labels of all medications in the class, cautioning physicians to be aware of an increased risk of heart failure occurring in these patients.

The FDA required the warning because it was concerned that “despite the warnings and information already listed on the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure.”

Reports were coming in about cases of weight gain and swelling — common warning signs for heart failure. In some of these patients whose therapy on a thiazolidinedione was continued, there were poor outcomes or even deaths.

FDA Warning: Actos Might be Linked to Bladder Cancer

In June 2011, the FDA issued another warning to be added to the drug label. Studies in theUnited StatesandFrancehad shown that the longer patients were on Actos at the highest cumulative doses, the greater their risk of getting bladder cancer.

The French study led that country to ban the sale of the drug in June 2011. Germany banned the drug the following day, because it too was concerned about the research statistics showing a strong link between Actos and bladder cancer.

In the U.S., on June 15, 2011, (the following week), the FDA issued a warning to healthcare providers and patients. The agency said that patients who had been on the medication for over a year and had the highest cumulative dose faced an increased risk of getting bladder cancer.

A new warning was required for the drug label. The FDA based its decision on an interim review of a ten-year study of Actos and bladder cancer being conducted by Takeda. The drug company still has five years to complete their study.

As with any medication, please contact your physician before stopping any drug including ACTOS and consult with them regarding your medical condition.