Recently, the U.S. Food and Drug Administration (FDA) released a safety announcement advising the public that long-term use (more than one year) of the prescription drug Actos (pioglitazone) may increase the risk of bladder cancer. In the same notice, the FDA states that this new safety information must now be put on the Warnings and Precautions label for Actos and other similar medicines, and that the patient Medication Guide for this drug must also be updated by the manufacturer.
This important notice from the FDA follows a similar notice from the European Medicines Agency (EMA) which has been conducting its own formal review of Actos and other pioglitazone-containing medicines since March 2011 at the request of the European Commission. Similar to the FDA study, the EMA is trying to determine the increased risk of bladder cancer associated with long-term use of pioglitazone-drugs, such as Actos.
The EMA’s announcement immediately followed the decision by the French Medicines Agency (Afssaps) to suspend the use of pioglitizaone-containing medicines in France following the results of a study that appeared to suggest an increased risk of bladder cancer with this type of drug.
In its own safety notice, the FDA writes:
The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.
If you or a family member are currently taking Actos or any other pioglitizaone-containing medicines, read this additional safety information from the FDA:
ACTOS – SAFETY INFORMATION
Information for Patients:
- There may be an increased chance of having bladder cancer when you take pioglitazone.
- You should not take pioglitazone if you are receiving treatment for bladder cancer.
- Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
- Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
- Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
- Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.
SOURCE: FDA Safety Announcement –June 15, 2011
ACTOS – SIDE EFFECTS
Actos may cause serious side effects including:
Bladder Cancer – There may be an increased chance of having bladder cancer when you take ACTOS. You should not take Actos if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer:
- blood or a red color in your urine
- an increased need to urinate
- pain while you urinate
SOURCE: FDA’s Actos Medication Guide
REMEMBER – You should NOT stop taking Actos, or any prescription medication, without first consulting with your physician.
REPORT — If you are experiencing any unexpected or serious adverse reactions to Actos, or any prescription medication, consult with your physician immediately, and please report these events to the U.S. Food & Drug Administration (FDA) using their online MedWatch Reporting Form.
YOUR RIGHTS – If you or a member of your family has suffered a serious injury caused by a related Actos side effect, you may be able to seek compensation for your losses and suffering. Please feel free to contact the law offices of Langdon & Emison for a free evaluation of your case.
