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The FDA approved the diabetes medication Actos in 1999. Since then, the medication has been repeatedly linked to an increased risk of bladder cancer. On June 15, 2011, the FDA released a safety communication warning consumers that taking Actos for more than a year could increase risk of bladder cancer by as much as 40 percent.

Despite these risks, on August 17, 2012, the FDA approved the first generic version of the drug, manufactured by Mylan Pharmaceuticals. Now, Consumer Reports has added its voice to the discussion and warns patients about the risks of both the brand name and generic versions of Actos.

Magazine Says Stay Away if Possible

In August 2012, Consumer Reports magazine stated, “We say skip Actos as both a generic and brand-name medication, unless other options have failed . . . other medications to treat diabetes, such as metformin, are a better first choice.”

This comes on the heels of yet another scientific study that found a link between the drug and bladder cancer. A study published in the July 3, 2012 issue of the Canadian Medical Association Journal found that taking Actos raised the risk of bladder cancer by about 20 percent. Lead author Jeffrey A. Johnson and colleagues examined data from over 2.6 million study participants.

An earlier study published in the May 31, 2012, issue of the British Medical Journal reported that those patients taking Actos for more than two years doubled their risk of bladder cancer.

Patients File Lawsuits Claiming Bladder Cancer

After the 2011 FDA warning, patients began to come forward to file Actos lawsuits. Most claim that the manufacturer, Takeda Pharmaceuticals, failed to warn them about the risks, and that, had they known, they would have chosen alternative treatment.

As the number of plaintiffs filing suit began to grow, the U.S. Judicial Panel on Multidistrict Litigation ordered that all federal cases be consolidated in the U.S. District Court for the Western District of Louisiana. The panel assigned the Honorable Rebecca F. Doherty to oversee the proceedings, which are expected to increase efficiency, reduce the risk of inconsistent rulings, and serve the convenience of all parties and witnesses.

In an order signed July 13, 2012, Judge Doherty scheduled the first bellwether trial to begin on November 3, 2014. The second is scheduled for January 12, 2015.

Patients Taking Generic May Have No Legal Recourse

In addition to concerns about Actos increasing the risk of bladder cancer, the generic version poses another risk. Unfortunately, patients taking the generic version of Actos may have no legal recourse should they be injured.

Though the new medication will provide cost savings for many diabetic patients, those who may suffer from bladder cancer may not be able to win compensation in court. A Supreme Court decision in the summer of 2011 ruled that generics are held blameless in cases of failure to warn as long as their drug labels match exactly those on the name brand drug.

Actos Also Increases Risk of Heart Failure

In addition to bladder cancer, Actos has also been linked with an increased risk of congestive heart failure. In 2007, the FDA mandated black box warnings concerning this potential side effect to be placed on all Actos packaging and advertising.

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