Texas Actos LawyerAugust 20, 2012 — Actos (pioglitazone) has recently been approved as a generic medication. On August 17, the U.S. Food and Drug Administration (FDA) announced that they granted Mylan Pharmaceuticals approval to produce generic Actos (pioglitazone) in 15 milligram, 30 milligram, and 45 milligram dosages. Pioglitazone is an oral type-2 diabetes medication that helps control blood-sugar levels.

 

Unfortunately, research has found that Actos may cause or worsen heart failure, especially for some patients. Researchers have also linked Actos to an increased risk of bladder cancer. In 2011, the FDA warned that using Actos for more than one year could increase a diabetic person’s risk of bladder cancer by 40%. Other studies have confirmed an increased risk of bladder cancer. Health authorities in France and Germany have restricted sales of Actos.

The generic version of Actos will have the same Black Box warning as the brand-name version of the drug, which will include information about the risk of heart failure and bladder cancer. A recent study found that these increased risks may be inherent to all thiazolidinediones (TZD) diabetes medications, which also includes Avandia.

Soon after the FDA granted Mylan Pharmaceuticals shared exclusive rights to produce generic Actos, Watson Pharmaceuticals sued the FDA. The shared exclusivity agreement would keep other generic drug companies from producing Actos for 180 days.

Watson had planned to sell a generic version of Actos beginning on August 17, 2012. In 2010, Takeda Pharmaceuticals, the Japanese manufacturer of Actos, gave Watson, Mylan Inc., and Ranbaxy Laboratories shared-exclusivity rights to market generic Actos for 180 days. Watson claims that they filed the correct paperwork, but the FDA denied Watson’s right to sell generic Actos in the shared-exclusivity agreement. Many generic drug companies are eager to start producing generic Actos — U.S. sales were $2.7 billion for the 12 months ending May 31, 2012.

Takeda is facing hundreds of Actos lawsuits from people who were seriously injured by the drug. The nationwide lawsuits have been centralized into a Multidistrict Litigation (MDL) in Louisiana. The judge overseeing the MDL has scheduled the first bellwether trials for 2014 and 2015, and these trials will set precedent for deciding the rest of the lawsuits. Most of the plaintiffs accuse Takeda of failing to warn about the risk of bladder cancer associated with Actos.

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