The ten-year study is looking at the incidence of bladder cancer associated with taking Actos among a group of over 193,000 patients enrolled in the Kaiser Permanente Northern California (KPNC) health plan. A five-year interim analysis reviewed by the FDA showed no overall increase in bladder cancer in patients taking Actos compared to patients never having taken Actos. Significantly increased risk of bladder cancer was seen, however, with the highest Actos doses and with taking Actos over extended periods of time. Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

The FDA is also conducting a comprehensive review of a study by the French National Health Insurance Plan. This study followed approximately 1.5 million patients with diabetes for a period of four years. The results indicated a significantly higher risk of bladder cancer in male patients taking Actos compared to patients taking other diabetes drugs, with the greatest risk occurring with higher Actos dosage and duration of treatment.

While the FDA will continue to review the available data and update the public accordingly, the FDA has not yet concluded that Actos increases the risk of bladder cancer. It has stated in the interim that healthcare professionals should continue to follow the recommendations in the drug labeling when prescribing Actos, and that patients should continue taking Actos as prescribed unless told otherwise by their healthcare professional. Patients concerned about their risks from taking Actos are encouraged to speak with their healthcare professional.

In the meantime, the FDA has approved updated drug labels for drugs containing Actos as a warning to healthcare professionals and patients of a possible increased risk of bladder cancer when taking Actos for longer than one year. Drugs containing Actos include Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended-release), and Duetact (pioglitazone/glimepiride). The updated labels recommend that healthcare professionals should not prescribe Actos drugs to patients having bladder cancer and to use caution in patients with a prior history of bladder cancer. Patients are encouraged to contact their healthcare professional if they see any signs of blood in their urine, new or worsening pain on urination, urination urgency, or pain in the back or lower abdomen since taking an Actos drug, as these symptoms may be signs of bladder cancer.

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