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More Than 100 Pending Cases Against Actos Combined Into A MDL

On December 29, 2011, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established multidistrict litigation (MDL) to consolidate more than 100 pending cases filed by Actos lawyers. The MDL is headquartered in the U.S. District Court for the Western District of Louisiana, and has added new cases throughout 2012. Pending lawsuits not in the MDL also incorporate claims of heart failure, especially congestive heart failure. These complaints are eerily similar to those of patients taking Avandia, a similar diabetes medication in the TZD drug class. Studies show that Avandia patients may risk a 43% increased chance of heart attack, which led to many alleged deaths and lawsuits.

Actos linked to heart problems

In 2005, the Lancet published a study linking high-risk Actos patients to a heart problems resulting from Actos use, specifically heart failure. Later, results from a post-marketing safety study confirmed this information: almost 10% of Actos patients may be hospitalized overnight for congestive heart failure.

Two years later in 2007, the FDA required a black-box warning to be added to the Actos label detailing possible side effects to inform consumers that Actos (pioglitazone) can cause or exacerbate congestive heart failure, especially for certain risk groups. The updated label also included warnings of edema and fluid retention, which are also risk factors for congestive heart failure.

Congestive heart failure and bladder cancer are side effects associated with Actos

Side effects resulting from Actos can be very serious. Studies show that the type 2 diabetes drug increases a patient’s risk of developing bladder cancer and congestive heart failure. In women, and especially in post-menopausal patients, Actos has also been associated with bone fractures in the feet, arms and hands.

One of the drug’s most prominent and dangerous side effects is bladder cancer. The link of Actos with bladder cancer is not yet fully understood, but experts believe that pioglitazone, which influences DNA transcription of certain genes, may cause genetic mutation or defects over the long-term, thereby increasing a patient’s risk of bladder cancer.

Studies show that cancer rates are higher in patients who have taken Actos in high dosages or for longer than 12 months, and that the drug can increase the risk of bladder cancer by 40%. In June 2011, the FDA warned the public of bladder cancer risks and in August 2011, the agency approved warning label updates to include the increased danger of bladder cancer.

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