Actos Side Effect Information – Frequently Asked Questions

If you were diagnosed with bladder cancer after using Actos, contact our dangerous drug lawyers for a free, confidential consultation by using the form at the bottom or by calling my office at (215) 931-2634. See also our Actos and Bladder Cancer page, our Actos News page, and my article (written for other lawyers) about the lawyer advertising for Actos lawsuits.

What happened (in one sentence)?

Patients using Actos (pioglitazone), the best-selling Type 2 Diabetes drug, have been found to have a much higher rate of bladder cancer than users of other medications, and so many patients have filed lawsuits seeking compensation for their injuries.

What has the FDA said about it?

On September 17, 2010, the FDA issued a Drug Safety Community noting that, five years into a ten-year study nearly 200,000 patients of the Kaiser Permanente Northern California health plan (all over 40 years of age and diagnosed with diabetes), a link had been found for patients who took Actos for more than 24 months, with a higher dose correlated with a higher risk of bladder cancer. The study was established by the maker of Actos, Takeda Pharmaceuticals, as a condition of FDA approval.

On June 15, 2011, the FDA issued an updated warning based on the Kaiser Permanente data that even just one year of pioglitazone use raises the risk of bladder cancer by more than 40%, or an extra 28 cases a year for every 100,000 people taking it. The FDA also recommended doctors not prescribe Actos for patients who have bladder cancer. For patients who had bladder cancer that was treated, “The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.”

On August 4, 2011, the FDA published new warning labels for Actos, which recommends doctors should not prescribe pioglitazone to patients with active bladder cancer, and exercise caution prescribing pioglitazone to patients with a prior history of bladder cancer. The drug labels recommend that patients should report to their doctor if they ”experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.”

Our firm believes it likely that Actos increases the risk of recurrence and that the FDA will eventually amend its recommendation to further restrict the use of Actos.

Has there been a recall of Actos?

The drugs have not been tainted or contaminated, and so there is no need to recall the medication already shipped and used. However, all patients taking Actos — or one of the drugs Actos is sold in combination with like metformin (Actoplus Met, Actoplus Met XR) or glimepiride (Duetact) — should raise the issue of bladder cancer with their physician and discuss both the symptoms of bladder cancer and the possibility of switching medications.

All patients either taking Actos or who have taken Actos should remain vigilant of symptoms of bladder cancer such as painful urination, frequent urination, urinary tract infections, blood in the urine, and pain in the lower back or in the abdomen. Anyone who experiences those symptoms should immediately consult with their physician. Patients may also wish to fill out a MedWatch Form with the FDA. Read more about bladder cancer at the National Cancer Institute.

What scientific studies have been done to determine the link between Actos and bladder cancer?

In addition to the Takeda Pharmaceuticals study of nearly 200,000 Kaiser patients mentioned above, European health officials have conducted a much larger study of 1.2 million patients taking pioglitazone. The results of that study, which also indicated a strong link between pioglitazone use and bladder cancer, prompted French officials to halt the use of pioglitazone (sold there as “Competact”) entirely, and prompted German officials to order clinicians not to prescribe the drug for any new patients.

The PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) study in 2005 that showed a correlation between Actos use and bladder cancer. See, Dormandy J.A., et al. Secondary Prevention of Macrovascular Events in Patients with Type 2 Diabetes in the PROactive Study, Lancet, 266:1279-1286 (2005).

In April of 2011, the American Diabetes Association published Piccinni, et al. Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting, Diabetes Care, 34:1369-1371 (formally published June 2011). Using adverse events reports made to the FDA between 2004 and 2009, the study concluded that data was “consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.”

Is there a class action lawsuit against the makers of Actos?

There are many individual pending lawsuits relating to Actos use and bladder cancer, but no pending class action lawsuits. For procedural reasons, class action lawsuits are rarely used in personal injury and dangerous pharmaceutical drug cases. Instead, many individual cases are filed, and sometimes the court consolidates the pre-trial proceedings for those cases in a special legal procedure called “multi-district litigation” or MDL.

Patients who have taken Actos and then developed bladder cancer may be entitled to compensation if Takeda Pharmaceuticals and related companies are found to have been negligent in the design, testing, manufacturing and marketing of their products. I’ve previously written articles on this blogs about the types of claims available against pharmaceutical manufacturers, like the most common claim, i.e. the “failure to warn” of the dangers.

Who might have a claim?

Although everyone who took Actos may have a theoretical legal claim arising from Takeda’s failure to properly warn of the dangers of Actos, many claims are not worth the monetary expense and emotional burden of pursuing litigation because they will likely not result in any sort of compensation.

At our firm, we closely follow the science, and we screen for cases in which the patient continuously used Actos for at least 12 months and thereafter developed bladder cancer. We also look at a person’s history of smoking; because heavy smoking is also strongly correlated with bladder cancer, heavy smokers may have difficulty proving that their bladder cancer was caused by Actos.

How did this happen?

Ironically, Actos became the top-selling diabetes control medication — despite a prior, known link to heart failure, stroke, and blindness — after Avandia, the primary competitor to Actos, was found in 2007 to dramatically increase risk of heart attacks. Avandia was banned in Europe and tightly restricted in the United States, but Actos was considered a safer alternative and so continued to be sold.

Unfortunately, Actos was not appropriately designed and tested prior to sale to the public. The studies now showing a link between pioglitazone and bladder cancer could have been done years ago; indeed, some of the strongest evidence now comes from animal studies, which could have been performed years ago.

If you were diagnosed with bladder cancer after using Actos, contact our dangerous drug lawyers for a free, confidential consultation by using the form at the bottom or by calling my office at (215) 931-2634. See also our Actos and Bladder Cancer page and my article (written for other lawyers) about the lawyer advertising for Actos lawsuits.

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