Actos Linked to Eye Disease and Bladder Cancer

Denver, COActos side effects are moving into the spotlight, now that the US Food and Drug Administration (FDA) has dealt with rival drug Avandia. Whether that is good news for patients on Actos remains to be seen. The FDA has recently issued a warning about the link between Actos and bladder cancer, and agencies in Europe have moved to take Actos off the shelves. Meanwhile, a study has linked Actos to a risk of eye disease, adding it to the list of potential Actos side effects patients may face.

The study, which was presented at the American Diabetes Association's annual meeting in June 2011, found that patients who take Actos and Avandia have three to six times the risk of developing diabetic macular edema, a condition that can result in blindness. According to Bloomberg (06/24/11), Actos had sales of $4.8 billion in the fiscal year ending March 2011.

Macular edema involves swelling of the retina, a condition that can ultimately result in blindness.

Meanwhile, the FDA issued a safety warning in June 2011 that use of Actos for more than one year could be linked to an increased risk of bladder cancer. That information will be added to the Warnings and Precautions section of Actos and other medications that contain pioglitazone.

The warning was issued after the FDA reviewed data from a study of pioglitazone. Although there was no overall increased risk of bladder cancer associated with the use of pioglitazone, there was an increased risk to patients with the longest exposure to the medication at the highest cumulative dose.

Actos is used to improve control of blood sugar levels in adults with type 2 diabetes.

The FDA notes that an epidemiological study in France suggests an increased risk of bladder cancer associated with use of pioglitazone. Based on the results of that study, France has suspended use of Actos, while Germany is recommending that physicians not start new patients on pioglitazone.

FDA recommends that physicians not start patients on Actos if they have active bladder cancer and further recommends that the medication should be used with caution in patients with a history of bladder cancer. Patients who are currently taking Actos are urged to speak with their doctor if they have symptoms of bladder cancer, including blood in their urine, pain while urinating or pain in the back or lower abdomen.