Actos (Pioglitazona)

Manufacturer: Takeda Pharmaceutical Company, Ltd
Recall Number: #FDA WARNING


Bladder Cancer

Heart Failure



Product Details

Actos (pioglitazone) 15 mg

Actos (pioglitazone) 30mg

Actos (pioglitazone) 45mg 

Summary by

Currently there has not been an official recall of Actos however the FDA has issued a black box warning about using the drug for more than a year and the increased risk of bladder cancer. Although the FDA has not issued a recall on Actos, it is notable that drug regulators in France and Germany have ordered doctors to stop prescribing Actos because of bladder cancer risks.

Federal Agency Description

[UPDATED 06/15/2011] 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. This safety information is based on FDA's review of data from a five-year interim analysis of an ongoing, ten-year epidemiological study. The five-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 with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.

Frequently Asked Questions

Who is at risk when using Actos?

Patients who have taken Actos for more than one year

Immediate steps to take if using Actos

If you have taken Actos for more than a year and are concerned about the possible risks you may want to stop taking the drug and consult with your physician before you continue use.

Is there an active lawsuit or settlement for people using Actos?

On April 7, 2014, a federal jury in Louisiana found Takeda failed to adequately warn about bladder cancer risks of Actos. Jurors also found that executives of Takeda acted with reckless disregard for patient safety and wellbeing and awarded $9 billion in punitive damages.

Am I entitled to financial compensation as a result of my Actos use?

If you have used Actos and developed some of the serious health complications that have been linked to the use of Actos especially bladder cancer (also, prostate cancer, bone fractures, heart failure) you may have legal options for compensation to cover medical expenses and other benefits. Click here to see if your eligible.

ALERT: As a result of the FDA warning you or a family member may be eligible to compensation