FDA Examines Safety Concerns over Diabetes Drug Actos


The Food and Drug Administration (FDA) is currently looking into safety concerns over the diabetes drug Actos after preliminary five-year data suggests long-term use of the drug may increase the risk of bladder cancer.

Actos is one of the two primary drugs marketed to help maintain proper blood sugar levels in diabetes patients. The data being evaluated by the FDA was generated from a ten-year study conducted by Takeda Pharmaceuticals, the manufacturer of Actos. The results of this study did not indicate a clear link between Actos usage and an increased risk of bladder cancer. However, the data did suggest that long-term use of the drug or taking it in high dosages may lead to an increased risk of cancer.

These findings are particularly alarming considering that the main alternative to the drug, Avandia, has also come under fire for causing several serious pharmaceutical injuries. In July, an FDA advisory committee debated whether Avandia should be removed from the market due to an increased risk of heart attack and stroke. In a highly contested and controversial vote, the panel narrowly voted not to pull the drug – 12 of 33 members voted for Avandia’s recall while 20 members voted to allow it to stay on the market with additional restrictions and warnings.

While the severity of the risks associated with these drugs have not yet been clearly defined, one thing is certain – diabetes patients must weigh a variety of adverse side effects when choosing between their options for controlling blood sugar levels.

The FDA review of Actos is currently underway and officials have advised patients to consult their doctor before discontinuing use of the drug.