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Generic Actos Is Approved By the FDA In Spite of the Risk of Dangerous Side Effects

The first generic version of the type 2 diabetes drug Actos was approved by the Food and Drug Administration (FDA) on August 17, 2012. The generic drug will be manufactured by Mylan Pharmaceuticals, who gained approval for the 15 mg, 30 mg, and 40 mg doses.

The FDA releases a communication regarding the possible connection between bladder cancer and Actos

Plaintiffs filing a lawsuit for bladder cancer from Actos typically blame Takeda for concealing what they already knew about the potential association between the drug and bladder cancer. An attorney representing a complainant in such a case is likely to note the two-year animal study that indicated cancerous tumors prior to FDA approval, as well as a 2005 study that indicated an association with bladder cancer.

In 2011, the FDA released a public safety communication noting the possible connection between Actos and bladder cancer. After reviewing the five-year results of a 10-year epidemiological study, they found that those who took the medication for more than a year were at a 40 percent increased risk of bladder cancer.

Similar studies led to a July 2011 French recall of the medication Actos.

Generic Actos will carry the same warnings as the name brand

The new generic form of Actos (pioglitazone) will carry the same warnings as the name brand equivalent. A black box warning will alert physicians and patients to the risk of heart failure. A new warning added in 2011 will alert users that taking the drug for more than a year may increase the risk of bladder cancer.

Many plaintiffs who have filed a lawsuit against Actos for their bladder cancer argue that this is still not enough. They claim that the company should include a second black box warning to be sure new patients are aware of the potential hazards of bladder cancer.

Those taking the new generic version would have an even harder time holding the manufacturer liable for inadequate warnings.

A Supreme Court ruling hinders a plaintiff’s ability to sue a generic manufacturer

On December 29, 2011, the U.S. Judicial Panel for Multidistrict Litigation centralized all federal lawsuits against Actos into one court in the Western District of Louisiana. Each plaintiff in the Actos MDL brings claims against Takeda. It remains to be seen if changes in policy will allow plaintiffs to bring claims against generic manufacturers. If not, those patients choosing to save money with the new generic may be taking the risk not only of developing bladder cancer, but having little recourse for recovering damages.

The generic version is bound to offer savings for many Americans, but plaintiffs continue to hire an Actos attorney to file cases against the manufacturer of Actos—Takeda—for failing to warn of the risks of bladder cancer.

A lawsuit against a generic manufacturer of the drug would be difficult to pursue should the user suffers an injury such as bladder cancer. The U.S. Supreme Court, in the summer of 2011, made a landmark decision holding generic manufacturers blameless for any such injury as long as their labels match identically with those of their brand name counterparts.

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