Actos Warning From FDA

Hundreds of thousands of diabetes patients have been re-considering their medication plans after a recent warning from the Food and Drug Administration (FDA).

On June 15, 2011, the FDA issued a safety communication reporting that use of the oral diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.

The FDA warned that patients with active bladder cancer should not be taking pioglitazone and those with a prior history should only use it after considering the potential medical benefits against the risk for cancer recurrence.

Actos is an oral drug used to treat type II diabetes, the most common form of the illness that plagues 25.8 million Americans. Actos is manufactured by Takeda Pharmaceutical Company and co-marketed by Eli Lilly and Company. It is one of the most widely used medications on the market. Over 2 million patients filled prescriptions for it in 2010.

The communication came as the FDA placed restrictions on Avandia, another popular medication, after studies showed it increased the risk of heart attacks. Both drugs belong to the thiazolidinedione class of drugs.

The warning about Actos came as the FDA made a periodic review of an ongoing 10-year Actos study into the risk for developing bladder cancer. The study reports there may be a 40 percent greater risk for developing bladder cancer among those who take Actos for more than a year.

The FDA’s warning came a new epidemiological study out of France suggested an increased risk of bladder cancer with pioglitazone use. As a result, France has suspended use of Actos and Germany has recommended new patients not be placed on the drug.

On August 4, 2011, the FDA reported it had approved new label and medication instructions for Actos. The FDA is continuing to monitor the results of Actos cancer studies.

Patients taking Actos should contact their doctors if they experience any sign of blood in the urine or a red color in the urine or other urinary pain, as these Actos complications may be signs of bladder cancer.

Click here to read the June 15, 2011 FDA Safety Communication on Actos.
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