FDA Warns of Bladder Cancer Risk from Actos

Diabetics taking Actos (pioglitazone) for more than one year may have a significantly increased risk of bladder cancer according to an FDA interim review of an ongoing epidemiological study.  The FDA warning came just days after Germany and France banned the use of Actos.  Five-year data from the ongoing study of more than 193,000 patients with diabetes shows that patients who used Actos for over one year or who used the hightest cumulative dose of Actos were at a greater risk of bladder cancer.  The same data does not reveal an increased risk with short-term use, although most diabetics will use the drug longer than 12 months.

The study shows a relative risk (RR) of 4.0 with a 2.8 to 6.6 confidence interval.  That is significant since a RR of 2.0 means a doubling of the risk.  According to the FDA, "compared to never being exposed to [Actos], a duration of [Actos] therapy longer than 12 months was associated with a 40 percent increase in risk [for bladder cancer]."  In addition, a French study showed a dose-response effect wehre risks for bladder cancer rose as time spent taking Actos lengthened beyond one year.

Actos is now the second drug in the thiazolidinedione (TZD) class of drugs to be associated with serious side effects.  In the fall of 2010, the use of Avandia (rosiglitazone) was severly restricted in the United States because of concerns about an incresed risk of heart attack.
 
What should I do if I take Actos?

Talk to your doctor!  The FDA advised doctors NOT to use Actos in patients with bladder cancer and to use it with caution in patients with a history of bladder cancer.  You and your doctor should weigh carefully the benefits of blood sugar control with Actos against the risks for bladder cancer or bladder cancer recurrence.

Also, the FDA advises that you should tell your doctor if you are having blood or red color in your urine, an urgent need to urinate, pain while urinating, or pain in the back or lower abdomen, as these may be symptoms of bladder cancer.

If you have bladder cancer and have taken Actos and wish to discuss your legal rights, please contact attorney Michael Phelan.  

Visit Michael Phelan's blog to learn more about the Actos cancer risk.


Sources:

FDA