Recent studies have shown that the popular Type 2 diabetes drug Actos may be associated with an increased risk of life-threatening side effects, including bladder cancer and cardiovascular problems like heart failure and heart disease. Unfortunately, Takeda Pharmaceuticals may have concealed the more serious side effects of Actos in an attempt to protect its medication from regulatory action, and former Actos users across the country are now pursuing legal claims against Takeda for bladder cancer, heart disease and other alleged side effects of the diabetes drug. If you took Actos to treat your Type 2 diabetes, and you have since suffered from a serious side effect like bladder cancer, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by allegedly dangerous drugs, and can put you in touch with a product liability lawyer who has experience handling Actos bladder cancer claims.
Research has shown that Actos treatment may be linked to an 83% higher risk of bladder cancer in patients, in addition to other serious side effects, like liver failure, heart disease and bone fractures. Rather than issuing an Actos recall over these devastating complications though, the FDA has said that it will continue to closely monitor ongoing Actos studies in the U.S. and abroad, in order to remain aware of these risks. In the meantime, people with Type 2 diabetes may be able to find safer alternatives to Actos for managing their diabetes, including the following natural remedies:
Actos (pioglitazone) is an oral Type 2 diabetes medication that comes in tablet form and belongs to a class of widely-used diabetes drugs called thiazolidinediones (TZDs). Actos is used to help control blood sugar levels in adults with Type 2 diabetes, which it does by decreasing insulin resistance, decreasing the glucose made in the liver, allowing the body to get rid of excess blood sugar more easily, and making the body more sensitive to insulin. Actos has been available in the U.S. since it was approved by the FDA in 1999, and the Type 2 diabetes medication is currently manufactured by Takeda Pharmaceuticals and marketed by Eli Lilly. With diet and exercise, Actos can help control blood sugar in people with Type 2 diabetes, but serious concerns have been raised in recent years about the potential link between Actos treatment and serious side effects, like bladder cancer, kidney disease and congestive heart failure.
In 2010, more than two million patients were taking medications like Actos (pioglitazone) to manage symptoms of Type 2 diabetes. Unfortunately, a growing number of studies, as well as numerous drug safety communications from the FDA, have suggested that the popular diabetes drug Actos may be linked to significant and potentially life-threatening side effects in users, including the following:
In light of these potential Actos side effects, the controversial diabetes drug has been pulled from the market in Germany, France and India. In the United States, however, the FDA has only recommended that physicians avoid prescribing Actos to patients with bladder cancer, and use Actos with caution in patients with a prior history of bladder cancer.
In June 2011, the FDA issued a safety announcement warning patients and healthcare professionals about the increased risk of bladder cancer possibly linked to the use of the diabetes medication Actos for more than one year. This FDA warning was based on the agency’s review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study conducted by Takeda Pharmaceuticals. According to the analysis, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone (Actos), and in those exposed to the highest cumulative dose of the drug. An additional epidemiological study was recently conducted in France, which also suggests an increased risk of bladder cancer with Actos use. Based on the results of this study, France has pulled Actos from the market, and Germany has recommended that physicians avoid starting Actos in new patients.
Actos currently carries a “black box” warning regarding the potential for the drug to cause or worsen congestive heart failure, a serious condition which prevents the heart from efficiently pumping blood. In 2007, the journal Lancet published a study in which researchers identified a significantly higher risk of heart failure in Actos patients, particularly in those with a history of heart disease or heart failure. The American Heart Association published a study in 2010 indicating that patients taking Actos or Avandia had a 4% higher risk of suffering from heart attacks, heart failure, or death, a significant percentage given the short study period.
December 2011 – Actos lawsuits filed in the federal court system are consolidated into a multidistrict litigation (MDL) in Louisiana for coordinated pretrial proceedings. The number of Actos cases is expected to reach 10,000.
March 2012 – A former consultant for Takeda, Dr. Helen Ge, files a federal whistleblower lawsuit against the drug maker, claiming that the company downplayed the severity of congestive heart failure risks tied to Actos.
February 2013 – The first lawsuit filed over bladder cancer side effects from Actos goes to trial.
April 2013 – Takeda Pharmaceuticals convinces a judge to throw out a $6.5 million jury verdict awarded to a California man who was diagnosed with bladder cancer after taking Actos.
September 2013 – A jury in Maryland finds Takeda guilty of downplaying the risk of bladder cancer from Actos, but a judge throws out the verdict and the $1.7 million in damages awarded to the plaintiff.
April 2014 – A federal jury in Louisiana awards $9 billion in punitive damages and $1.5 million in compensatory damages to a New York man who claimed that Actos caused his bladder cancer.
June 2014 – A ruling by a federal judge indicates that Takeda Pharmaceuticals intentionally destroyed documents that were considered critical to 3,000 product liability lawsuits involving Actos side effects.
October 2014 – A Philadelphia jury awards $2 million in compensation to a woman who was diagnosed with bladder cancer after taking Actos.
February 2015 – A Man who was diagnosed with bladder cancer after using Actos for three years is awarded $2.3 million in damages by a jury in the Philadelphia Court of Common Pleas.
April 2015 – Takeda agrees to settle about 9,000 Actos bladder cancer lawsuits for at least $2.37 billion, in one of the largest pharmaceutical settlements in the history of U.S. mass torts.
August 2007 – The FDA upgrades the Actos label to its most serious “black box” warning, highlighting the risk of heart failure associated with the diabetes medication.
September 2010 – A drug safety communication issued by the FDA warns about a potential connection between bladder cancer side effects and the use of Actos for longer than two years.
June 2011 – The FDA issues an updated drug safety communication warning the public that use of Actos for longer than one year may increase the risk of bladder cancer by 40%.
June 2011 – Actos is banned in France and Germany, following a report issued by the French Medicines Agency, which highlights the risk of bladder cancer linked to the controversial diabetes drug.
August 2011 – The FDA informs the public in a safety alert that it has approved updated warning labels for pioglitazone-containing drugs to include information about an increased risk of bladder cancer with treatment that lasts longer than one year.
October 2012 – The Institute for Safe Medicine Practices (ISMP) identifies a “surge of reports” submitted to the FDA over adverse events, including at least 1,025 cases of bladder cancer from Actos since early 2011.
Prior to being approved by the FDA in 1999, premarket studies show that bladder tumors can develop in animals exposed to Actos.
September 2007 – A study published in the Journal of the American Medical Association definitively links Actos treatment to an increased risk of heart failure and other cardiovascular events.
April 2008 – Research published in the journal JAMA Internal Medicine provides further evidence that people who take TZDs like Actos face an increased risk of bone fractures, particularly hip and wrist fractures, compared to people taking other diabetes drugs.
June 2011 – The French Medicines Agency conducts its own Actos study and finds that users of the Type 2 diabetes drug have a 22% higher risk of bladder cancer than patients taking other diabetes medications. French medical regulators issue a recall for Actos, due to a “statistically significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents.”
May 2012 – The British Medical Journal publishes a study indicating that diabetes patients taking Actos may have an 83% increased risk of bladder cancer.
June 2012 – The use of Actos more than doubles the risk of a serious eye disorder called macular edema, which can result in vision loss and blindness, according to a study published in The Archives of Internal Medicine.
June 2012 – A study published in the Journal of the American Medical Association finds that patients who take Actos for an extended period of time may face an 83% greater risk of developing bladder cancer.
June 2012 – Research published in the Journal of the National Cancer Institute finds that long-term use of Actos, Avandia and other thiazolidinedione drugs (for five years or longer) is associated with an increased risk of bladder cancer.
July 2012 – The Canadian Medical Association Journal publishes research linking the Type 2 diabetes drug Actos to a 22% increased risk of bladder cancer. The researchers also report that other medications in the thiazolidinedione class of diabetes drugs are tied to a 15% higher risk of bladder cancer.
January 2014 – In a study published in the journal PLoS One, researchers from the Kaohsiung Medical University in Taiwan find that Actos use is associated with a four-times increased risk of chronic kidney disease.
July 2015 – According to the findings of a 10-year study commissioned by the FDA and published in the Journal of the American Medical Association, Actos is tied to a 41% increased risk of pancreatic cancer and a 13% increased risk of prostate cancer.
Federal regulators have seen a surge of adverse event reports involving Actos and bladder cancer since the connection first came to light years ago, and the FDA reportedly received 1,025 reports of Actos bladder cancer complications from the beginning of 2011 to late 2012 alone. According to lawyers representing victims of Actos bladder cancer side effects, Takeda knew as early as 2004 that Actos may increase the risk of bladder cancer in users, but waited for seven years to issue a warning about this risk, in order to protect billions of dollars in sales of the drug. Lawsuits filed against Takeda Pharmaceuticals over Actos bladder cancer side effects accuse the company of:
An emerging body of research has suggested that Actos may no longer be safe in treating patients with type II diabetes. If you or a loved one has suffered from a major side effect and you believe Actos to be the cause, contact an Actos attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, the medical cost of treating your injuries, and the pain and suffering endured by you and your family. The main goal of Actos attorneys is to help victims of potential Actos side effects protect their rights and collect the compensation they deserve. Drug companies like Takeda Pharmaceuticals are expected to produce and distribute safe medications, and should be held liable for any adverse side effects sustained by consumers of their products. By hiring an experienced Actos lawyer to represent your case, you may be able to hold Takeda Pharmaceuticals accountable for your injuries.