Several studies confirm a potential link between Actos and bladder cancer risk.

Actos, a blood sugar control medication for patients with type-2 diabetes, is in a drug class known as thiazolidinediones. Along with competitor Avandia, Actos controls blood sugar levels by making sure the body uses insulin more sufficiently. While some studies have linked Avandia to an increased risk of heart failure and heart disease, only Actos has been linked to an increased risk of bladder cancer.

Actos is made and marketed by Takeda Pharmaceuticals. More users recently are worried about Actos and bladder cancer risk. 

In 2005, a clinical trial indicated an association between Actos (pioglitazone) and bladder cancer risk. The U.S. Food and Drug Administration (FDA) added a warning about the potential risk to the drug’s label in 2011.

In December 2016, the FDA rejected the findings of a 10-year study that Takeda had commissioned that indicated Actos caused no increased risk of bladder cancer.

In 2017, an analysis of Medicare data determined a link between Actos and bladder cancer risk. Elizabeth M. Garry, MPH and fellow researchers determined patients who took Actos developed bladder cancer at a rate of 308 per 100,000 person-years. That number was compared with the rate of bladder cancer cases among patients taking DPP-4 inhibitors, which was 204 per 100,000 person-years. The drugs Januvia (sitagliptin), Galvus (vildagliptin), Onglyza (saxagliptin) and Tradjenta (linagliptin) are all DPP-4 inhibitors.

The analysis of Medicare data also determined the rate of Actos and bladder cancer risk was greater than that of patients who were taking sulfonylureas, which was 231 cases of bladder cancer per 100,000 person-years. Amaryl (glimepiride), DiaBeta and Micronase (both glyburide) and Glucotrol (glipizide).

Actos and bladder cancer risk increased within the first 24 months of treatment and increased over time, reported Garry.

In 2016, researchers in Canada came to the conclusion that the Actos bladder cancer risk increases the longer the patient takes the medication. The March 30, 2016 issue of BMJ published the study that indicated the risk of bladder cancer increases in patients who take the drug longer than two years or the equivalent of more than 28,000 milligrams in their lifetime.

Canadian researchers analyzed data of more than 145,000 patients who received Actos between 2000 and 2013. One researcher said the risk of bladder cancer increases because Actos accumulates in the body.

Actos and Bladder Cancer Risk Allegedly Hidden

Takeda has come under fire for allegedly knowing since 1996 of the link between Actos and bladder cancer risk. Takeda’s own researchers detected abnormal bladder cells had developed in mice and rats that had ingested Actos. Abnormal cells often are precursors to cancer cells.

Takeda allegedly hired a researcher to put forth a bogus reasoning that the cell deformation detected in rats didn’t apply to humans, and that hypothesis helped Actos receive FDA approval in 1999.

In 2015, Takeda agreed to a $2.4 billion settlement in an MDL that consisted of nearly 9,000 claims made by patients and family members who said they were not properly warned of the risks of Actos and bladder cancer risk.

If you or a loved one has taken Actos and subsequently been diagnosed with bladder cancer, you could be eligible for compensation through legal means.