Mass Tort

Actos®

Burg Simpson is not currently pursuing new Actos® cases.

In April 2015, Actos® manufacturer Takeda Pharmaceuticals agreed to a $2.4 billion settlement to resolve the claims of thousands of patients who took Actos® and developed bladder cancer. The agreement requires that at least 95% of eligible claimants agree to the terms of the settlement, which will compensate plaintiffs based on their age, the extent of their bladder cancer injury, the cumulative dosage of Actos® used, and history of certain risk factors for bladder cancer, including smoking. This is one of the largest pharmaceutical industry settlements in history. Read more about the Actos® settlement here.

The United States Food & Drug Administration (FDA) and the European Medicines Agency (EMA) have issued urgent safety alerts regarding the Type-2 Diabetes drug Actos® (pioglitazone).
On June 15, 2011, the FDA issued an urgent health warning to doctors/patients that Actos® may increase the risk of bladder cancer by up to 40%. Long-term users of Actos and those exposed to higher cumulative doses are among the groups at the greatest risk.

The FDA now requires that these recent findings and risks be included in the Warnings and Precautions section of the label for Actos® and other pioglitazone-containing medicines. In the meantime, the FDA has chosen not to issue an Actos® recall and the drug remains available to consumers in the United States despite these alarming statistics.

Symptoms of Actos®-related Bladder Cancer May Include:

• Blood in urine
• Change in urine color
• Frequent urination
• Painful urination
• Urinary tract infection

Actos® And Bladder Cancer: History

Actos® originally received FDA clearance in 1999. At the FDA’s request, Takeda Pharmaceuticals agreed to undertake a 10-year epidemiological post-market study in 2002, investigating the questions raised about Actos® and bladder cancer. An interim analysis of the data produced from the study showed an increased likelihood of bladder cancer developing in patients who took Actos® for the longest periods of time and at the highest cumulative doses. The FDA has informed the public that “… use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” According to the FDA’s warning, “Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk.

No U.S. Actos® Recall Despite Health Risks

The FDA now requires that information about this increased risk be added to the Warnings and Precautions section of the label for Actos® and other pioglitazonecontaining medicines. At this time, the Agency has stopped short of issuing an Actos® recall. The FDA “stresses that there is no definitive proof that Actos® causes bladder cancer and that patients who are currently taking it should continue to do so, unless otherwise advised by their healthcare provider.”

Actos® And Type-2 Diabetes

• Actos ® (pioglitazone) is manufactured by the Japanese drug company Takeda, and is co-marketed in the United States by Eli Lilly Pharmaceuticals.
• Actos® is an oral medication used to treat Type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone.
• More than 2.3 million people were prescribed Actos® in 2010.
• Actos® belongs to a family of drugs known as Thiazolidinedione (TDZ), which are drugs used to lower blood sugar levels and increases the body’s sensitivity to insulin.
• The active ingredient in Actos® (pioglitazone) is also used in combination with other Type-2 diabetes therapies in other medicines such as Actoplus met®, Actoplus met® XR and Duetact®.
• Actos® became the world’s most popular Type-2 diabetes medicine in 2007, after medical studies linked Avandia , a similar drug produced by GlaxoSmithKline, with a 40% increased risk of heart attack.
• Approximately 20 Million Americans suffer from Type-2 Diabetes.
• According to the National Cancer Institute, there were more than 70,00 cases of bladder cancer in the U.S. in 2010, resulting in 14,680 deaths.

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