Since 1958, The Beasley Firm has fought for injured patients and consumers, recovering over $2 billion for our clients through hundreds of multi-million dollar settlements and jury verdicts. If you developed bladder cancer after taking Actos, contact our dangerous drug lawyers for a free and confidential consultation by filling out the online form below, by calling The Beasley Firm’s main line at (215) 592-1000, or by calling my office directly at (215) 931-2634.

Actos (pioglitazone) was previously the best-selling Type 2 Diabetes drug in the world but has since come under scrutiny following several scientific studies which revealed that patients on Actos has a far higher rate of bladder cancer than patients on other diabetic glucose control medications.

On September 17, 2010, the FDA issued a Drug Safety Community noting that, five years into a ten-year study of any association between Actos and bladder cancer, 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.

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.”

On June 15, 2011, the FDA issued an updated warning 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 or have had bladder cancer.

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. GlaxoSmithKline, the makr of Avandia, has as of this date settled about 12,000 of Avandia lawsuits for around $700 million.

Other data, such as animal studies involving mice, has indicated a connection between pioglitazone and bladder cancer, particularly in males.

Like GlaxoSmithKline, the maker of Actos, Takeda Pharmaceuticals, may be legally responsible for damages arising from the increased risk of bladder cancer. Bladder cancer is typically treatable if caught early, but many of our clients’ oncologists have described the bladder cancer associated with Actos as unusually aggressive and quick to reoccur — likely because the patients continued using Actos even after the cancer was diagnosed, because they and their physicians were unaware of the risks. Unfortunately, even if the chemotherapy treatments and surgeries are performed properly, they can lead to infertility, impotence, and other reproductive problems. Takeda Pharmaceuticals may be responsible to pay compensation for those damages.

As I have discussed on this website before, many courts have sharply restricted defective drug design lawsuits, but many patents’ legal claims remain viable if they are handled appropriately by experienced attorneys.

Many of the Actos lawsuits filed have alleged that Takeda Pharmaceuticals declined to publish data from 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). If true, Actos could be liable for its failure to warn patients of that increased risk. Many lawsuits have also alleged that Takeda Pharmaceuticals was negligent in its design and testing of Actos by failing to investigate and react the potential link with bladder cancer.

Actos is sometimes sold in combination with metformin (Actoplus Met, Actoplus Met XR) and or in combination with glimepiride (Duetact). Diabetic patients who have been diagnosed with bladder cancer should review their medications and speak with their physicians to determine if their control medication included pioglitazone.

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 Side Effect Frequently Asked Questions page, our Actos News and Information page, and my article (written for other lawyers) about the lawyer advertising for Actos lawsuits. You can also read more about my firm at The Beasley Firm website.