Actos Side Effects and Litigation
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed November 29, 2023
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Actos (pioglitazone) is a popular Type 2 diabetes medication. The U.S. Food and Drug Administration (FDA) approved the drug in 1999. Takeda Pharmaceuticals manufactures this medication, which enjoyed early financial success. However, Takeda's patent on Actos expired in 2012. This fact, along with negative publicity about the drug's serious side effects, led to a decline in sales.
This article will explain the side effects of Actos. It will also briefly discuss the state and federal lawsuits plaintiffs filed against both Takeda and the co-manufacturer of the diabetes drug, Eli Lilly and Company. While the multi-district litigation against the pharmaceutical company closed in April 2018, plaintiffs have sued Takeda Pharmaceuticals and Eli Lilly for injuries caused by other drugs.
What Is Diabetes?
Diabetes is a common disease characterized by the human body's struggle to produce and absorb insulin. By far, the most common form is Type 2 diabetes, affecting 90% of the 26 million Americans with diabetes. Its chief characteristic is high blood sugar levels.
There is no cure for diabetes, and the disease can lead to serious health problems. However, it's treatable. Regularly monitoring blood sugar levels is essential to managing the disease. Most patients can rely on diet and exercise to control their blood sugar levels and live happy lives.
Diabetes medications such as Actos may also be able to lower blood sugar levels.
Serious Side Effects
Before we discuss the possible side effects of Actos, it's important to point out that people with Type 1 diabetes should not take this medication. People take the drug to treat Type 2 diabetes.
Like most drugs, there are potential side effects of taking the prescription drug. Many of these are minor and don't cause any permanent health risks. However, there are also severe side effects that can lead to long-term injuries and even death.
Some of the common side effects of Actos include:
- Headache
- Upper respiratory infection
- Weight gain
- Muscle pain
- Sinus infections
- Sore throat
- Trouble breathing
- Shortness of breath
The side effects most patients worry about are the severe side effects. According to experts at the Mayo Clinic, some of the more serious adverse events associated with the drug Actos include the following:
- Hypoglycemia
- Bone fractures
- Congestive heart failure
- Bladder cancer
- Liver damage or failure
- Low blood sugar
- Macular edema
- Heart attack
- Increased risk of heart disease
If you or your loved one suffers any of these health issues after taking Actos, contact a personal injury lawyer immediately. You may have a claim for damages like thousands of other patients.
Heart Failure
In 2007, the FDA determined that the thiazolidinedione (TZD) class of diabetes medications, which includes Actos, may cause heart failure in some patients. Specifically, the drug increases a patient's risk of congestive heart failure.
The FDA required that Takeda place a black box warning, the FDA's strongest warning, on Actos labeling to alert consumers of the increased risk for heart failure.
Bladder Cancer
Many Actos patients sued Takeda and Eli Lilly after developing bladder cancer. In 2011, the FDA announced that long-term use of Actos may be associated with an increased risk of bladder cancer. The FDA approved the risk information on Actos labeling after carefully reviewing a ten-year-long medical study on Actos.
The study revealed that patients with greater exposure to Actos faced an increased risk of bladder cancer. Consequently, the FDA advised healthcare professionals to avoid prescribing Actos to patients with bladder cancer or a history of bladder cancer.
Legal Liability
Many Actos users filed product liability lawsuits against Takeda. Under product liability law, manufacturers and sellers must ensure that the products they place in the market are free from unreasonable defects or dangers. The difficulty with prescription drugs is that many of them have inherent risks.
Plaintiffs in the Actos lawsuits claimed that the defendant failed to warn them of the risks associated with Actos. Specifically, they argued that Actos caused bladder cancer, macular edema, and heart disease.
Takeda should have warned patients and healthcare providers of the risks of Actos, but instead they hid internal communications that confirmed the risks. So many plaintiffs sued the drugmaker that the federal government consolidated the lawsuits into one MDL action. A judge for the Western District of Louisiana oversaw the multidistrict litigation (MDL).
Takeda and their co-defendant, Eli Lilly, settled the federal cases for $24 billion. Each plaintiff received an average of $200,000. While the company did agree to settle, Takeda remained steadfast that their drug did not cause bladder cancer. On April 11, 2018, the court deemed the cases resolved and closed the MDL.
Many plaintiffs sued the drug manufacturer in state court as well. Takeda faired much better in state court. The defendant managed to get many of the verdicts against them overturned on appeal.
What Should I Do if I Develop Bladder Cancer After Taking a Type 2 Diabetes Medication?
If you or a family member take a type 2 diabetes medication and develop an illness, you may have a legal claim. The best thing to do is talk to a personal injury lawyer near you. They can review your claim and let you know how best to proceed.
Next Steps
Contact a qualified product liability attorney to make sure your rights are protected.
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