Actos FDA Warning

In the spring of 2011, interim results from a 10-year safety study involving type 2 diabetes patients found that long-term users of medicines containing Actos had 40 percent more bladder cancers than people who had never taken it.

As a result, the Food and Drug Administration warned patients and physicians in June 2011 that taking Actos-containing medicines for more than 12 months may have a higher bladder cancer risk. The FDA also required stronger warnings on drug package inserts.

In light of the findings, Takeda Pharmaceuticals, the maker of Actos, said it stands by Actos and is committed to Actos and Actos-containing medicines.

Bladder Cancer Observed in Early Actos Studies

The FDA had asked Takeda, to undertake this safety study because bladder cancer was observed in early drug tests involving animals and people. Although the interim results uncovered a potential risk, the study is moving forward until it concludes at the end of 2012, when the FDA says it will re-evaluate the drug.


The safety study involves 193,099 type 2 diabetic patients who are members of the Kaiser Permanente Northern California health plan. Of the total, 30,173 people took medicines containing Actos. The median duration of use among them was two years, which means an equal number of Actos users took it less than 2 years and an equal number of them took it more than 2 years.

Bladder Cancer Risk Increased with Dose and Duration

As a group, Actos users didn't have a significantly higher bladder cancer risk than those who never used the drug. But when researchers considered increased duration and cumulative doses taken over longer periods, a significant bladder cancer risk emerged. Anyone who took Actos for more than 12 months and consumed the highest cumulative doses had a 40 percent greater risk of getting bladder cancer.

France Issues Actos Recall

Days before the FDA warning, France suspended use of Actos because its own studies found similar results. Germany suspended use in new patients. The European Medicines Agency, the European Union's drug safety agency, recommended Actos be used only as a last-resort drug for people whose disease has been unresponsive to other medications. (See Actos recall.)

In addition to the advisory and package insert update, the FDA said Actos shouldn't be prescribed to anyone currently being treated for bladder cancer and should be prescribed cautiously to anyone with a bladder cancer history.

The agency told Actos users to alert their physicians to any bladder cancer symptoms, including blood in the urine and a change in bladder habits. Patients were urged not to stop taking their medicine because uncontrolled blood sugar could also damage their health. Instead, they were advised to consult with their doctors.

Actos Lawsuits Filed in Federal Court

By July 2011, 54 lawsuits had been filed in federal court against Takeda Pharmaceuticals by patients who said their bladder cancer was caused by Actos-containing medicines. By December 30, 2011, a federal judge consolidated these suits, and others that have since been filed, before a Louisiana judge in the Western District of Louisiana in Lafayette.

To join these lawsuits, or feel you might be entitled to Actos compensation, request a free case evaluation now. has experts in defective-drug litigation who can assess your claim and help you decide what to do.

Next Article : Actos Facts At a Glance