Patients who have been taking ACTOS, a popular diabetes drug, have been warned by the FDA that there is an increase in the risk of bladder cancer when the drug is ingested for more than 12 months.
According to US News, the FDA’s warning of the increased possiblity of bladder cancer by 40% comes five years after France and Germany pulled ACTOS from the market in their countries. The reason Germany and France pulled the prescription drug off of the market was for the same reason — the increased possibility of bladder cancer.
The risk of bladder cancer will now appear as a warning on the labeling of the prescription drug.
ACTOS is part of a class of drugs called thiazolidinediones. They are a class of medications used to treat diabetes mellitus type 2. Thiazolidinediones were introduced in the late 1990’s. The only other member in these types of drugs is called Avandia, which was removed from shelves in the United States earlier this year because of concerns of increased risks of heart attacks.
Specifically, it is used to control blood sugar. The drug was sold to more than two million patients in 2010. The new warning that bladder cancer may result after long periods of using ACTOS comes after studies conducted by FDA. One such study conducted by FDA involved more than 193,000 patients with diabetes. The patients in this study were on ACTOS for an average of two years. FDA said, “Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40 percent increase in risk [for bladder cancer].”
Since releasing the studies, the FDA has advised doctors not to use the prescription drug ACTOS in patients with bladder cancer and to use caution with other patients who have had bladder cancer.
Notwithstanding the serious risk, the manufacturer of ACTOS, Takeda Pharmaceuticals North America Inc., has told reporters that the company remains positive about the drug. In a press statement, Takeda Pharmaceuticals North America Inc. said that it is "confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. The company remains committed to Actos and Actos-containing medications, and to the millions of people living with the disease."
If you or someone you know took Actos for more than a year and developed bladder cancer, you deserve compensation for the financial, emotional and physical pains you suffered through. Takeda Pharmaceuticals had a legal and moral responsibility to thoroughly research all possible harmful side effects of Actos and notify users, doctors and the FDA of any risks. Until the FDA’s mandated label change, the Actos label did not warn consumers of the increased risk of bladder cancer. By filing a claim, you can get the compensation you deserve, and you can help hold Takeda responsible for this negligence.