The Food and Drug Administration has announced that it has approved an updated warning label about the link between the diabetes drug Actos and bladder cancer. The FDA had previously announced that it would strengthen warnings about an Actos bladder cancer link in June 2011.
The FDA’s Actos warning was issued after preliminary results from a 10-year study revealed that patients taking the drug for more than one year or who used the highest doses of the drug were more likely to be diagnosed with bladder cancer. Patients taking other drugs with the same active ingredient (pioglitazone) as Actos—including Actoplus Met, Actoplus Met XR and Duetact—were also included in the new bladder cancer warning.
The FDA’s new warning about Actos advises doctors not to prescribe the drug to patients with active bladder cancer and to use caution in prescribing the drug to patients with a history of the disease. The agency has also advised patients to speak with their doctor if they experience any bladder cancer symptoms while taking Actos, including blood in the urine, urinary urgency, lower back pain or abdominal pain.