Actos

Problem Summary

Research shows that Type 2 diabetes patients taking Actos may face a significantly increased risk of bladder cancerand other serious complications, and there is evidence that Actos maker Takeda Pharmaceuticals became aware of the risk of bladder cancer from Actos in the early 2000s, but deliberately withheld this information from doctors and patients.

Without treatment, Type 2 diabetes can lead to blindness, heart disease, nerve and kidney damage, but a number of scientific studies published in recent years have suggested that Actos treatment can lead to bladder cancer and other potentially life-threatening side effects in users.

If you took Actos for Type 2 diabetes and you have since suffered bladder cancer, cardiovascular problems, bone fractures, or another serious side effect, you may have grounds to file an Actos injury lawsuit against Takeda Pharmaceuticals and Eli Lilly and Company.

About Actos

Actos (pioglitazone) is a prescription antidiabetic medication manufactured by Takeda Pharmaceuticals and formerly marketed in the United States by Eli Lilly. Actos was approved by the FDA in 1999 for the treatment of Type 2 diabetes in adults, and when used in combination with diet and exercise, the drug has been shown to improve blood sugar control.Type 2 diabetes is a condition where the body fails to efficiently produce insulin and is therefore unable to effectively regulate sugar levels in the blood.

Actos, a thiazolidinedione (TZD) drug, works by increasing the body’s sensitivity to insulin and decreasing the amount of sugar stored in the liver, thereby helping to lower blood sugar levels. When Actos first entered the market in the United States, it was very well received and quickly became a popular treatment for Type 2 diabetes. However, side effects began to be reported among Actos users and the drug has since been linked to a number of serious health risks.

“In 2015, Takeda Pharmaceuticals agreed to pay over $2.4 billion to settle more than 8,000 Actos lawsuits. In addition to lawsuits filed by Actos users who developed bladder cancer, the anti-diabetic drug has been the subject to lawsuits for congestive heart failure and other serious injuries.”

Actos Side Effects

Before Actos was approved by the FDA for human use, animal studies showed that the diabetes drug’s active ingredient caused bladder tumor growth in male rats. After Actos’ approval, the FDA asked Takeda Pharmaceuticals to conduct a post-marketing study to address concerns about the development of bladder cancer in the pre-marketing animal studies. Thus, Takeda launched a 10-year epidemiological study, of which a five-year interim analysis (from 2003 to 2008) showed an increased risk of bladder cancer in patients taking Actos for more than two years.

These results were reviewed by Takeda in 2009, but it wasn’t until 2010 that they were reported to the FDA,and it wasn’t until 2011 that they were finally published.That same year, an analysis of the FDA’s adverse event reporting system found that, from 2004 to 2009, bladder cancer side effects were reported 4.3-times more often with Actos than with other diabetes drugs.

The FDA has issued a number of warnings regarding the potential for Actos to cause bladder cancer and other side effects in users. One of the first FDA warnings came in 2007, when the FDA added a “black box” warning to the Actos label regarding the potential risk of heart failure in Actos users.

In 2010, more than a decade after Actos’ approval, the FDA issued a drug safety communication regarding an ongoing safety review of Actos and the potential increased risk of bladder cancer associated with treatment lasting two years or more. The following year, the FDA issued two updated drug safety communications, the first indicating that diabetes patients who use Actos for more than one year may face an increased risk of bladder cancer, and the second requiring updated drug labels for Actos to reflect this risk.

In December 2016, the FDA confirmed the potential risk of bladder cancer from Actos, citing additional studies reviewed by the agency, and indicating that healthcare professionals should “carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.”

In addition to a potential increased risk of bladder cancer, Actos treatment may put users at risk for other serious side effects, including bone fractures, congestive heart failure, macular edema, chronic kidney disease and lactic acidosis, among other medical problems. Despite these potential risks, Actos has yet to be recalled in the United States.

Actos Resources & Studies

• Actos Black Box Warning
• Actos Settlement 2019
• September 2010 Actos FDA Drug Safety Communication
• 2011 Report Publishing the Interim Results of Takeda’s 10-Year Study
• June 2011 Actos FDA Drug Safety Communication
• Drug Regulators in France and Germany Order Doctors to Stop Prescribing Actos
• August 2011 Actos FDA Drug Safety Communication
• December 2016 Actos FDA Drug Safety Communication

Actos Settlements & Litigation

At its peak, Actos was the best-selling diabetes drug in the United States, with sales over $3.85 billion, but the medication has become the subject of considerable scrutiny in recent years, following the publication of several studies linking Actos to a significantly increased risk of bladder cancer.

Thousands of lawsuits have been brought against Takeda Pharmaceuticals and Eli Lilly for injuries allegedly caused by Actos treatment, and all of these lawsuits involve similar allegations that the companies knew or should have known about the potential for Actos to cause bladder cancer and other serious side effects and failed to issue adequate warnings about these risks.

In fact, in 2012, a former employee sued Takeda, accusing the company of hiding details from the FDA about the potential risk of Actos side effects, namely the drug’s connection to a dozen variations of cancer. Jurors in the case found that Takeda Pharmaceuticals intentionally destroyed documents pertaining to the development, marketing and sale of the drug, and ordered the company to pay $155,000 over the spoliation of evidence.

In 2014, the first case from the Actos multidistrict litigation (MDL) went to trial and resulted in a multibillion-dollar verdict against Takeda.The Louisiana jury ordered Takeda to pay $1.5 million in compensatory damages and $6 billion in punitive damages to the plaintiff for its “wanton and reckless” conduct in failing to adequately warn about the potential risk of bladder cancer from Actos treatment. The jury also ordered Eli Lilly to pay $3 billion in punitive damages.

The jury award was later reduced to $36.8 million, with fault assigned to Takeda (75%) and its marketing partner, Eli Lilly (25%).In 2015, Takeda agreed to pay a total of $2.4 billion to settle nearly 9,000 claims over allegations that the company was negligent in testing and designing Actos and failed to warn the public about the increased risk of bladder cancer.

More recently, in May 2018, a class action lawsuit was filed against Takeda and Eli Lilly, alleging that diabetes patients paid for an “inefficacious and dangerous” medication. The lawsuit also alleged that the drug companies intentionally concealed the risk of Actos side effects, knowing that “if the medical community were aware that Actos could cause bladder cancer, it would not have been the blockbuster drug they needed Actos to be.”