Elevated rates of bladder cancer have been seen in diabetic patients taking the prescription drug Actos®. Cases of malignant tumors have been linked to long-term use of this medication, and plaintiffs have begun to take legal action against the manufacturer of the drug, Takeda Pharmaceuticals. Victims who have experienced adverse complications after being prescribed the medication have already been awarded billions of dollars in settlements.
Qualified pharmaceutical attorneys are currently investigating cases involving bladder cancer, congestive heart failure, and other adverse complications from Actos®. If your family has been affected by this potentially dangerous medication, please contact an experienced attorney to discuss your legal rights.
About Actos® Therapy
Actos® is an insulin sensitizer medication that has been widely prescribed to patients with type 2 diabetes for over 15 years. It is in the same drug class as Avandia, another widely-prescribed drug that triggered many lawsuits.
Actos® (pioglitazone hydrochloride) is in the thiazolidinediones drug class, which works to reduce insulin resistance in type 2 diabetic patients. With improved insulin sensitivity, the cells in the body work more effectively to maintain consistent blood sugar levels. Actos® also reduces the amount of glucose that is produced by the liver. Taken orally in a single daily dose, it is designed to prevent long-term complications from diabetes.
Many patients have been prescribed Actos® since it was released in 1999, and thousands have reported serious complications. Bladder cancer has been among the most frequently reported adverse outcomes associated with this drug.
Bladder Cancer and Actos®
Reports of bladder cancer in long-term Actos® patients began to emerge in the early 2000s. A study of adverse event reports sent to the U.S. Food and Drug Administration (FDA) between 2004 and 2009 found almost one-fifth of the diabetic patients reporting bladder cancer had been prescribed Actos®. The FDA issued a safety announcement in 2010, warning of the possible risk, particularly in patients who were exposed to high cumulative doses (more than 28,000 mg.) of the drug.
In 2011, the FDA issued a stronger safety warning concerning the drug. This warning stated that the increased risk of bladder cancer was associated with the use of Actos® for over a year. Takeda was required to update the drug’s warning labels at this time and add bladder cancer to the list of potential complications. This warning was prompted in part by a study from France that showed higher incidences of bladder cancer in patients using pioglitazone compared to other diabetes treatment drugs. France and Germany responded by banning Actos® prescriptions, and India also later followed suit.
A potential link to bladder cancer was initially seen in Takeda’s own preclinical research. During the company’s animal trials in the 1990s, bladder tumors were found in male rats exposed to the drug’s active ingredient.
A medical study published in the British Medical Journal (BMJ) in 2012 confirmed an elevated risk of bladder cancer connected to Actos® therapy. The study demonstrated that patients taking Actos® for longer than 12 months showed an increased incidence of bladder malignancies. The highest risk was found in patients taking the drug for more than two years.
Mounting Evidence of Cancer Connection
The results of a recent Montreal medical study reported in the March 2016 issue of The BMJ showed a 63 percent increased risk of bladder cancer associated with Actos®. Over 145,000 patients who took the drug between the years of 2000 and 2014 were studied by researchers, confirming the link that Takeda has long tried to deny.
If you have been injured by a defective drug, Speak with an Attorney
Court documents from a whistleblower lawsuit filed against Takeda show the company knew about patient complications and tried to conceal them from the public. Former medical reviewer Dr. Helen Ge indicated that she was directed to understate reports to the FDA pertaining to congestive heart failure and cancer. She stated that she was asked to report 72 Actos® bladder cancer incidences instead of over 100 that had actually been observed. Dr. Ge analyzed FDA adverse event reports from patients who were prescribed Actos® and Avandia from 1999 through 2010. Her findings included 1,813 cases of pancreatic, bladder, and other types of cancer reported by patients taking Actos® for a year or less.
Legal Response to Complications
Many lawsuits have been filed by patients suffering from bladder cancer after Actos® treatment. In 2011, many of these cases were consolidated into multidistrict litigation (MDL) in Louisiana. MDL is common in defective drug cases, and allows courts to handle multiple similar claims with greater efficiency. The Actos® lawsuits included personal injury and wrongful death cases alleging that Takeda failed to properly warn doctors and patients about the serious risks of bladder cancer.
A lawsuit was filed by the family of a Louisiana man, who took Actos® from 2002 to 2010 to control his type 2 diabetes. He was subsequently diagnosed with bladder cancer, which proved fatal in his case.
Many similar cases have been brought against the manufacturer, with significant jury awards handed down to the victims. Not all cases were favorable for the plaintiffs, but those that were often involved multi-million-dollar compensation awards.
In April 2015, Takeda agreed to a $2.37 billion settlement of more than 9,000 MDL cases. This is one of the largest pharmaceutical liability settlements on record. This was not the end of the litigation process for Takeda, however. Additional cases were settled in October 2015, including a $2 million settlement for a Pennsylvania woman suffering from bladder cancer. There are now several class action lawsuits pending in Canada, and many additional claims in the U.S.
Other diabetes treatment drugs linked to serious complications include Invokana®, an SGLT2 inhibitor associated with kidney failure and diabetic ketoacidosis, and Onglyza®, a DPP inhibitor connected to cardiac problems.
Contact Our Legal Team
If you have experienced a complication from Actos® or another prescription medication, your family may be entitled to legal compensation. Please contact an experienced attorney for a free case evaluation.