Actos, also known as pioglitazone, is a Type 2 Diabetes drug that first came under Food and Drug Administration (FDA) scrutiny for being linked to higher risks of heart attack, heart failure, stroke, and other cardiovascular issues. And although the Agency issued a Black Box warning for these risks in June of 2007, the FDA has yet to recall or further limit this drug’s usage in the U.S. This lack of FDA action may soon change, however, as recent studies linking Actos to risks of bladder cancer have prompted all prescriptions for the drug to be suspended in both France and Germany.
FDA action limiting or eliminating the use of the drug in the U.S. has been a possibility since September 2010 when the FDA announced that it was studying the drug’s link to bladder cancer. A response by the federal government is much more likely to happen now that a French study has linked an increased risk of bladder cancer to the drug. There, a study of 155,000 Actos patients found a 22 percent increase in bladder cancer when compared to individuals taking other diabetic drug regimens. Additionally, this French study looked at the dosage level of each patient and found that there was roughly a 50 percent increase in bladder cancer for those who took higher dosages of the drug.
Acting in response to these findings, Illinois-based Actos manufacturer Takeda is defending the drug by pointing to the results of a two-year long clinical study (published in the Journal of Diabetes Care) that seem to downplay any risk of cancer with Actos. This study’s authors conclude that: “[s]hort-term use of [Actos] was not associated with an increased incidence of bladder cancer”, but that “use for more than 2 years was weakly associated with increased risk.”
The Boston Globe, however, made the argument that this Actos-friendly article misinterprets the study’s findings. The newspaper reported that the study’s data actually showed a 40 percent increased occurrence of bladder cancer for patients who took the drug for at least 2 years. Additionally, this increased risk is not a recent revelation. According to the Los Angeles Times, Takeda knew that male rats exposed to the drug showed an increase number of bladder tumors before Actos was even marketed.
Wexler Wallace attorneys are investigating all claims against the manufacturers of Actos, which is also sold in combination with Actoplus Met, Actoplus Met XR, and Duetract. While the ultimate conclusion on the risks associated with Actos has not been made final, we believe any risk of a potentially terminal cancer should outweigh any benefit of being prescribed the drug. If you would like us to investigate your potential claim for injuries related to Actos, please click here.