FDA Actos Bladder Cancer Warnings

Dangers posed by Actos have caught the attention of the FDA as well as drug safety regulators around the world. In France, Actos was banned in 2011 due to the threat of Actos bladder cancer. In Germany, physicians were advised not to prescribe Actos to any more patients. Actos is still available for use in the United States, yet Takeda Pharmaceuticals agreed to a settlement of $2.4 billion to keep Actos bladder cancer lawsuits from going to trial.

Two separate warnings from the FDA concern the danger of bladder cancer from taking Actos. FDA Actos bladder cancer warnings were issued in September of 2010 and June of 2011, more than ten years after the drug was approved by the FDA. The first warning suggested there may be a risk of Actos causing bladder cancer, but did not confirm such a danger. The second FDA Actos bladder cancer warning, issued less than a year later, confirmed the risk and took the step of requiring a bladder cancer warning on the Actos drug label.

2010 FDA Actos Bladder Cancer Warning

The FDA Actos bladder cancer warning in 2010 was the first time the American public had been warned of the risk of Actos bladder cancer, even though the pharmaceutical company had known of the risk for some years. At that time, the FDA believed that patients had to have been exposed to the drug for two years before their bladder cancer risk increased. Based on this information, many patients believed they were immune to the risk if they took Actos for a period shorter than two years.

• Do not stop taking your Actos unless told to do so by your healthcare professional.
• FDA has not concluded that Actos increases the risk of bladder cancer. The Agency is reviewing this safety concern and will update the public when additional information is available.
• Talk to your healthcare professional if you have concerns about Actos.
• Report any side effects from the use of Actos to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

2011 FDA Actos Warning

In 2011, the FDA amended its warning, stating that a year was enough time to increase the risk of bladder cancer development, even at the lowest dose. Research conducted by the FDA revealed that patients who took Actos for one year were exposed to a 40% increase in risk of developing bladder cancer. In fact, research found that patients taking higher doses, such as 30-45 mg, could develop cancer much sooner. Some researchers say there is a threshold for cancer risk; once a patient has taken 28,000 mg over time, their chance of developing cancer rises dramatically according to this research.

The following information was provided to patients in the revised FDA bladder cancer warning:

• There may be an increased chance of having bladder cancer when you take pioglitazone.
• You should not take pioglitazone if you are receiving treatment for bladder cancer.
• Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
• Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
• Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
• Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Takeda Pharmaceuticals knew of the risk of Actos bladder cancer from early testing it conducted on animals, yet did not add a warning to the drug’s label until the FDA forced the company to do so. In the years before the first FDA Actos bladder cancer warning was issued, the drug brought in annual sales as high as $6 billion.

Actos Bladder Cancer Lawsuits in U.S. District Court

Companies that flagrantly ignore and conceal drug risks in order to make profits should be held accountable for their deplorable actions. More than 9,000 Actos lawsuits were consolidated as a multidistrict litigation known as Actos (Pioglitazone) Products Liability Litigation in U.S. District Court in the Western District of Louisiana. In late April of 2015, the pharmaceutical company Takeda Pharmaceuticals agreed to a settlement of $2.4 billion. On average, claimants included in this settlement can expect to receive more than $260,000 apiece. One of the benefits of multidistrict litigation, unlike class action lawsuits, is that the details of each case are preserved and settlements are figured individually, depending on the circumstances of the case.

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Actos Bladder Cancer Lawsuits

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Actos Bladder Cancer Information from RxWatch:

• Actos Bladder Cancer Lawsuits Main
• Actos Bladder Cancer Research
• FDA Actos Bladder Cancer Warnings
• Actos Bladder Cancer Lawsuits
• Actos Cancer Lawsuit FAQs