When St. Louis attorney Anthony Gray found out that the U.S. Food and Drug Administration had sent out a warning that long-term use of the diabetes drug Actos (pioglitazone) puts patients at increased risk for bladder cancer, he took it personally.
“When I learned it was potentially tied to type 2 diabetes, instantly I became concerned because I knew about the disproportionate impact diabetes has on the African-American community,” Gray said. “A lot of people, we anticipate, will be affected and don’t know it.”
Gray is an attorney with Johnson Gray, LLC in Clayton, Mo. His firm is partnering with Kelley Law Group PC in Boston, in conjunction with the law firm Goldenberg Heller in Edwardsville, Ill., to seek compensation for damages to bladder cancer patients who were taking Actos, made by Japan’s largest drugmaker, Takeda Pharmaceutical.
The FDA’s warning is based on a planned five-year interim data analysis of an ongoing 10-year study. A previous study in France concluded that long-term use of Actos and higher cumulative doses significantly increased the risk of bladder cancer. Germany no longer allows new patients to use the drug.
“When we took a look at what these studies were finding and what kind of action there has been in other parts of the world, we started to become very interested in what the impacts would become in the United States overall since there is such a high incidence of diabetes in our country,” said Walter Kelley, of Kelley Law Group PC in Boston.
“In our opinion, we allege that the manufacturer of the drug, Takeda Pharmaceuticals, had the duty to warn patients about this increased risk, and we allege that they failed to meet that duty.”
Kelley said he represents clients with bladder cancer who have taken Actos. Although he did not want The American to speak directly with his clients, Kelley provided a scenario for one who reportedly took Actos to treat type 2 diabetes from December 2006 through July 2011.
In June 2008 a doctor noticed a mass in this patient’s bladder during a prostate procedure, and a biopsy confirmed the tumors were malignant.
“The patient had been experiencing blood in his urine and urinary tract symptoms prior to this diagnosis,” Kelley said. “Due to cancer being invasive but confined to the bladder, surgeons performed a urinary diversion and requires the use of an exterior ostomy pouch, which he wears like a belt around his waist.”
Kelley said the client must empty the pouch daily when it becomes full of urine.
“He suffers from sexual dysfunction and frequent urinary tract infections since the surgery to remove the cancer,” Kelley said. He had no family history of this type of cancer.
“Because his doctors were unaware of the possible link between Actos and bladder cancer, he continued taking Actos up until he noticed the FDA patient safety warning in June of 2011,” Kelley said.
“When he mentioned the FDA warning to his doctors, they immediately discontinued Actos and switched him to another medication to control his diabetes.”
Kelley said they are looking for people that have taken the drug Actos and have been diagnosed with bladder cancer.
“Actos is a widely prescribed drug, it’s Takeda’s blockbuster drug,” Kelley said. “And there’s been a lot of litigation in this class of drugs.”
The other diabetes drug in this class of drugs is Avandia, made by GlaxoSmithKline. It was restricted for use by the FDA after it was linked to increased risk of serious heart problems, like heart attacks and strokes.
“They’ve pushed their clients on Actos because they thought it would be a safer alternative,” Kelley said. “And now what are now seeing is that the doctors were unaware that they could be potentially be putting their patients on something that could expose them to an increased risk of bladder cancer.”
Actos, like Avandia, is linked to increased risk of cardiovascular events. The Takeda website, actosinfo.com warns that “Actos can cause or worsen heart failure.”
“We are not telling people they should discontinue taking Actos simply because it may cause an increased risk of bladder cancer,” Kelly said.
Rather, patients should raise the issue with their doctor, he said, and “at that point they can make an informed decision on whether or not the risk is warranted.”
In response to the FDA safety announcement, a joint statement was released from the Endocrine Society, American Association of Clinical Endocrinologists and the American Diabetes association. They urged patients who are currently taking Actos, or any combination medication that includes the drug, to continue taking all currently prescribed medications unless instructed otherwise by their healthcare provider.
They stated, “Stopping diabetes medications can result in higher levels of blood glucose that may cause serious short-term health problems and could increase the risk of diabetes-related complications in the long term.”