Close up of bottles of Actos sitting on pharmacy shelf


Actos® is a drug prescribed to treat Type II Diabetes. It was originally approved for use by the Food and Drug Administration (FDA) in 1999. The primary ingredient in Actos, pioglitazone, increases the body’s sensitivity to the hormone insulin, which helps naturally regulate blood sugar levels. Combined with diet and exercise, it was believed that Actos could help patients with Type II Diabetes better control and manage their condition.

Risks Associated with Actos

Multiple studies by the FDA concluded that Actos® can, in fact, lead to serious and potentially deadly side effects in patients.

One of the most dangerous side effects of this medication is that Actos has been closely linked to an increased risk of bladder cancer in patients. In 2011, the FDA concluded that using the drug Actos for a period of 24 months or longer correlated to roughly a 40% increase in a patient’s risk of developing bladder cancer.

Other serious and potential side effects of Actos include:

• Increased risk of congestive heart failure
• Eye disease and eye swelling is also known as Macular Edema
• Increased risk of bone fractures in female patients
• Liver and kidney disease and failure

Warnings to Patients

Actos was never officially recalled from the U.S market, despite the many known dangers and risks it posed to patients.

In 2007, Actos received a Black Box warning from the FDA. This boxed warning label alerted patients about the potential increased risks of developing congestive heart failure while taking the medication; however, this Actos warning label made no mention of the increased risk of bladder cancer.

In 2010, the FDA finally issued a formal safety announcement about Actos and the associated risks of patients developing bladder cancer. The FDA announced that after conducting a ten-year study on the drug, they had determined that higher levels and longer periods of exposure to Actos had a strong link to bladder cancer.

Despite these multiple red flags about the safety of this drug, Actos remained available to patients in the United States, even after it had been deemed unsafe and recalled in other major markets such as Germany and France.

Protecting Your Rights as a Victim

In April of 2015, the Japanese pharmaceutical company Takeda, the manufacturer responsible for creating and distributing the defective drug Actos®, agreed to pay a settlement to victims in the amount of $2.4 Billion. Over 9,000 victims filed liability claims against Takeda after developing bladder cancer from the drug Actos.

At Graves McLain, we understand the effects of Dangerous Medication and have the legal and medical knowledge necessary to take on major pharmaceutical manufacturers on behalf of our clients. We have seen far too many patients harmed by dangerous medications and are here to protect your rights.

If you or a loved one has developed bladder cancer, congestive heart failure, or any other serious medical condition while taking the diabetes medication Actos, call Graves McLain today at (800) 390-6600 for a FREE and confidential consultation.

Time may be running out to file your claim, so call Graves McLain today to learn how we may be able to help.

When you trust our firm to represent you, you will never pay an attorney’s fee unless we achieve a recovery for you. We don’t get paid until you do.

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