Study finds bladder cancer link in prolonged Actos use

Health agencies' reactions range from recommending label changes to imposing outright bans

Actos continues to be prescribed in the United States, but in two European countries there now exists a complete ban on the drug due to concerns over its safety.

France and Germany recently imposed bans in response to a study by the French Public Health Insurance Office, published in June, 2011, which found that patients taking Actos 24 months or longer face an increased risk of developing bladder cancer.

Elsewhere in Europe, health officials recommended that warning labels be added to Actos packaging as a way to alert doctors, nurses, pharmacists and other health workers to the bladder cancer risk.

The U.S. Food and Drug Administration has taken a similar stance with regard to Actos here amid growing reports of patient injuries, moving to implement its own new labeling requirements.

Actos — developed by Takeda Pharmaceuticals — is billed as a therapy to reduce insulin resistance, a problem common among patients with Type II diabetes. The medication belongs to the thiazolidinediones class of drugs and can be prescribed in three strengths. Patients take it orally in pill form, usually once a day (with or without food).

The precise mechanism through which Actos can cause bladder cancer remains unknown. Additionally, other, less severe, side-effects are possible, including headache, sinus infection, toothache, muscle pain, sore throat, water retention, fatigue, stomach cramps, jaundiced eyes, and appetite loss.

Visit the FDA's website for more information about Actos risks. Contact an Actos lawyer for more information about your legal rights and options if you were injured by taking Actos.