The U.S. Food and Drug Administration (FDA) is informing the public that the use of the diabetes drug Actos (pioglitazone – a drug in the thiazolidinedione or TZD class of Type 2 Diabetes drugs) for longer than a year, can be associated with an increased risk of bladder cancer. Information about this risk will be added to Warnings and Precautions section of the label for medications that contain Actos.
There will also be a revision to the medication guides for these medications to include the risk of bladder cancer.
This information came to light when the FDA reviewed data from a planned 5-year interim analysis of an ongoing 10-year study.
The 5-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients using Actos the longest, and in those patients taking the highest cumulative dose of pioglitazone.
The FDA is also aware of a recent epidemiological study conducted in France, which suggests an increased risk of bladder cancer with pioglitazone.
Based on the results of this study, France has suspended use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.
FDA recommendations are as follows:
- Not to use Actos in patients with active bladder cancer.
- Use Actos with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with Actos should be weighed against the unknown risks for cancer recurrence.
So here are some key takeaways if you are taking Actos:
- There may be an increased chance of having bladder cancer when you take Actos.
- You shouldn’t take Actos if you’re receiving treatement for bladder cancer.
- Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
- Read the medication guide you get along with your Actos medicine. It explains the risks associated with the use of Actos.
- Talk to your doctor if you have any questions or concerns about Actos.
- Report side effects from the use of Actos or Actos containing medications to the FDA MedWatch program, using the information in the “Contact Us”
Actos is in the TZD class of oral drugs that treat Type 2 diabetes. The other drug in this class is Avandia, which has received bad press over the past few years and is restricted for use in the United States, and was pulled off the market in Europe.
Currently patients must be enrolled in a special program to receive Avandia through mail order. And after November 18, 2011, Avandia will no longer be available through retail pharmacies.
Why do Doctors prescribe Actos or Avandia?
In my 8-plus years of experience, physicians really like TZDs, but have been reluctant as of late to write Actos, the only of the two still widely available in the U.S. They have told me that they don’t feel that the risk will outweight he benefit in most cases. This class of drugs has received a bad rap over the years. The first TZD to come out over a decade ago, Rezulin (troglitazone) was pulled from the market because of increased risk of liver toxicity in patients taking the drug.
This class of drugs has been shown to be very effective at reducing insulin resistance and improving beta cell function in people with Type 2 diabetes. These are two core defects of type 2 diabetes. Not to mention, these drugs therapeutic effects last very long compared to other drugs on the market.
There is data that shows that this class of drugs can help to control blood sugars for up to 5 years. So there are a number of people who have been on these medications for a number of years. Also, these drugs have been shown to lower A1C, 3-month measure of blood sugar control, by some of the largest reductions seen of any other class of drugs on the market.
Prior to using any of this information, please consult with your doctor.