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FDA Denies Takeda’s Actos Replacement For A Second Time

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On the heels of the medical debacle with its type 2 diabetes drug Actos (pioglitazone), drug maker Takeda Pharmaceuticals failed to win federal drug clearance for its replacement diabetes drug.

It seems the U.S. Food and Drug Administration (FDA) is being extra cautious when it comes to its approval of Takeda’s new drug, alogliptin and the combination of alogliptin and pioglitazone.

Or perhaps the FDA is still smarting from the backlash from the severe side effects of Actos, which has left scores of patients with bladder cancer, heart failure and a host of other medical conditions.

Either way, now Takeda is back to the drawing board on its drug. According to Bloomberg news, Takeda had planned for the new drug as a serious revenue generator after it loses its patent on Actos later this year.

This is the second time the drug has been rejected. The first time was in 2009 because the FDA requested more data on the drug’s cardiovascular risks. It’s unclear why the FDA rejected the drug this time.

Perhaps, the drug’s ties to Actos is giving the FDA pause. The active ingredient in Actos, pioglitazone, has been linked to an increased risk of bladder cancer, heart failure and other serious life-threatening complications.

Today, a 10-year study into the dangers of Actos continues. The first five years of the study showed an increase risk of bladder cancer in those taking the drug for longer than a year. The drug also carries a black-box warning for its heart-failure connection.

Around the world, drug regulation agencies have taken action against Takeda and the drug’s link to bladder cancer. In Germany and France, Actos has been removed from the shelves. More recently, in Canada, health officials underscored the Actos-bladder cancer connection and took the drug off the country’s list of approved medicines.

Canadian health officials also demanded that Takeda issue a written warning to health-care professionals. No such letter has gone out to doctors in the U.S. In fact, the only action that has been taken to alert the public of Actos-related bladder cancer in the U.S. is a blurb on the drug’s warning label.

Already, hundreds of patients have sued Takeda in federal and state courts. In the Louisiana district court, hundreds of patients have signed on to a multidistrict litigation (MDL), which is starting to grow legs. The attorneys in the case had their second meeting with the judge overseeing the MDL and are moving forward with discovery process.

The judge overseeing the cases in the Illinois state court is seeing an increasing number of cases each day. And in Los Angeles, the judge was supposed to hold a status conference on April 16 for the dozens of cases filed there, but the conference was continued until May 7.

If you are a diabetes patient who has taken Actos and developed bladder cancer, congestive heart failure or any other side effects, call (800) 452-0949. You will be able to speak with a Patient Advocates who can explain how you can receive compensation for medical expenses related to Actos injuries.

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