Diabetes Patients Sue Drugmaker After Actos® Causes Cancer And Other Complications
For the millions of patients nationwide suffering from type-2 diabetes, the medication Actos® (pioglitazone) was supposed to be a revolutionary way to control blood sugar levels. But in the years since the drug was released onto the market, patients have suffered debilitating and even life-threatening side effects of Actos, including the development of bladder cancer, heart problems, and renal failure.
Actos Linked to Cancer Development and Other Serious Side Effects
Actos was approved as a blood sugar medication in 1999, and was marketed to work alone or in conjunction with common diabetes drugs metformin and insulin. The product quickly became one of the most popular drugs used to treat diabetes in the United States, making nearly $3 billion for drugmaker Takeda Pharmaceuticals in the first decade on the U.S. market. However, studies quickly mounted showing the dangers of the medication, including chronic conditions that can lead to serious health complications and death.
Dangerous side effects of Actos may include:
- Bladder cancer. A 2012 study discovered that patients who took Actos long-term suffered an 83 percent increased risk of bladder tumors and recurrence of past bladder cancer. Patients who used the drug for over a year also suffered twice the risk of developing cancer as those who were not on the drug.
- Heart failure. The FDA has issued a black-box warning for Actos due to its established risk of heart failure in patients with and without pre-existing heart conditions. Actos causes two side effects that have been linked to the development of heart failure: severe weight gain and water retention (edema). In combination, Actos® patients are overwhelmingly likely to suffer congestive heart failure over time.
- Bone fractures. Women who are taking Actos are at increased risk of bone fractures, suffering breaks at a rate two or three times greater than women on other diabetes medications. The majority of fractures occurred in the arms, hands, and feet.
- Kidney disease. Actos may also be harmful to the kidneys, causing painful urination, blood in the urine, and even renal dysfunction. A 2014 study of over 35,000 diabetes patients found evidence of chronic kidney disease in over 8 percent of participants taking Actos. In some cases, symptoms occurred even in patients who were talking very low doses of the drug and had used it for less than a year.
Takeda Pharmaceuticals Pays Over $2 Billion to Settle Cancer Lawsuits
Despite FDA warnings and mounting evidence of adverse health risks, Takeda never issued a recall of Actos in the U.S. In fact, Takeda’s own clinical trials showed evidence of Actos’ tendency to cause bladder tumors and bladder cancer, causing the FDA to issue its black-box warning. Other countries, including France, India, and Germany, chose to recall the drug from their markets due to Actos’ risks, but Takeda still denied that any increased risk of cancer was present.
The tide began to turn against Takeda Pharmaceuticals in 2015. The company agreed to settle thousands of Actos lawsuits accusing the drugmaker of causing cancer in patients. The agreement will resolve nearly 9,000 bladder cancer cases, paying patients an estimated $2.37 billion to settle complaints of failure to warn consumers and hiding known risks of a dangerous drug.
The settlements in these cases can be significant in offsetting the costs of cancer treatment, especially for individuals. In a 2014 judgment, Takeda was ordered to pay $6 billion to former Actos patient Terrence Allen, who developed bladder cancer. Allen was awarded $1.5 million in compensatory damages and $6 billion in punitive damages from Takeda, as well as $3 billion from the drug’s marketer Eli Lilly. The total award was later reduced to $38.6 million.