Actos is a prescription drug used to treat type-2 diabetes and is part of the anti-diabetic drug class known as thiazolidinediones. It is also known by its generic name, pioglitazone. Actos is manufactured by Takeda Pharmaceuticals, and was approved by the U.S. Food and Drug Administration (FDA) back in 1999.

Actos works to treat type-2 diabetes by controlling blood sugar when used in combination with proper diet and exercise in diabetic patients. The drug may also be prescribed in combination with metformin, another medication used to lower blood glucose.

Type-2 diabetes diminishes a person’s sensitivity to insulin, and the drug Actos lowers blood sugar by increasing a patient’s insulin sensitivity, thereby increasing the amount of insulin produced. This drug is reportedly only effective in patients with insulin as it requires naturally secreted insulin to work. Therefore, Actos is reportedly not effective in patients with type-1 diabetes since they have little to no insulin in their bodies.

What Are the Side Effects of the Drug Actos?

Like many drugs, Actos comes with its risks of side effects and complications.

Some common side effects of Actos, according to WebMD, may include headache, muscle pain, weight gain, tooth problems, and symptoms resembling those of a cold, including stuffy nose, sinus pain, sneezing, and a sore throat.

Other more severe side effects include shortness of breath, pink or red urine, difficulty urinating, vision changes, and unusual pain in extremities. The drug may also cause liver disease which can present with symptoms including dark urine, yellowing of the eyes/skin, persistent nausea and vomiting, and stomach/abdominal pain.

How Do I Know if I Am Allergic to the Drug Actos?

Emedicinehealth.com notes that patients may develop an allergic reaction to Actos, and should seek emergency medical attention if this occurs. An allergic reaction may take the form of hives, difficulty breathing, swelling of face, lips, throat, and tongue.

Is Actos safe?

Unfortunately, Actos is associated with some less common, but more dangerous risks. Some patients who have taken the drug say they developed bladder cancer.

Bladder cancer is one of the most common types of cancer—about 68,000 adults in the U.S. are diagnosed with bladder cancer each year. While it is often diagnosed in the early stage, even early-stage bladder cancer is commonly recurring, so patients typically require follow-up tests for years.

It has not been proven that Actos causes bladder cancer — merely that some patients who took Actos report developing bladder cancer.

In 2011, the FDA added a warning label to pioglitazone about the potential risk of bladder cancer, and continued to review the medication over the next several years.

In December 2016, the FDA concluded that Actos and other pioglitazone medications may be associated with an increased risk of bladder cancer. The agency noted that the drug should not be prescribed to patients with active bladder cancer and may not be the best decision for patients with a bladder cancer history.

Patients are encouraged to seek medical attention if they experience symptoms of bladder cancer, including blood in the urine or red/pink urine, new or worsening urge to urinate, and/or pain when urinating.

“Overall, we conclude that pioglitazone may be associated with an increased risk in urinary bladder cancer, and we have updated the drug labels to include information about these additional studies,” the FDA noted.

Emedicinehealth.com goes on to say that Actos may increase a patient’s risk for serious heart problems and that this risk may be in addition to the already elevated risk that diabetics have for health problems. Because of these risks, the drug is not recommended for patients with severe or advanced heart disease.

Have Patients Filed Lawsuits Over the Drug Actos?

More than 10,000 lawsuits have been filed over Actos’ alleged risks. Patients have claimed that the drug’s maker, Takeda Pharmaceuticals, should have warned patients of the drug’s possible link to bladder cancer and heart problems, among other alleged side effects.

Despite these lawsuits, Takeda still maintains that Actos is effective and safe. However, the company has reached settlements — ending some 9,000 claims. In 2015, Fortune reported that Takeda had offered to settle the Actos lawsuits by paying $2.2 billion in Actos settlements. Before these settlements were announced, juries had given verdicts that would have required Takeda to pay $22 million to people allegedly injured by the drug.

Not just patients have filed Actos lawsuits. An Actos safety consultant claimed that Takeda intentionally misrepresented the drug as safer than it is to the FDA. Her claims were dismissed, but a consultant said that Takeda concealed knowledge that the drug could increase patients’ risk to over a dozen types of cancer.

Have Patients Been Warned About Possible Actos Risks?

Some patients claim that Takeda and Eli Lilly, the company that marketed the drug, should have warned patients of risks associated with the drug.

French and German health regulators banned Actos after a French study indicated that it could increase a patient’s risk for bladder cancer.

In a less extreme move, the FDA mandated an update to the Actos label, warning that the drug “may be associated with a 40 percent increased risk of bladder cancer.”

Filing an Actos Bladder Cancer Lawsuit

If you or someone you love has been diagnosed with bladder cancer after use of Actos, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by bladder cancer or other serious health complications, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially in the wake of a cancer diagnosis or the death of a loved one, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.