Actos Recall

Has Actos been the subject of a recall?

The diabetes drug Actos has come under fire recently. Manufacturer Takeda Pharmaceuticals faces hundreds of lawsuits from plaintiffs who allege that they developed Actos bladder cancer after taking the drug. Actos is no longer available in France or Germany, but the FDA has allowed the controversial drug to remain on the market in America. Many patients who have filed an Actos lawsuit believe that the drug should be subject to an Actos recall in America, complaining that the combination of Actos bladder cancer lawsuits and European regulators’ decision to ban the drug should be enough to convince the FDA to issue such a recall.

Actos Recall in Europe

French regulators acknowledged the risk of Actos bladder cancer in June 2011 by pulling the drug from shelves and ordering doctors to stop prescribing it to patients. Although patients were advised to keep taking Actos unless otherwise directed by their physicians, France’s  recall led the European Medicines Agency to conduct their own analysis of the French study.

Following France’s decision to issue a recall of Actos, German medical regulators quickly ordered physicians to suspend the use of Actos in new patients until further information on the risk of Actos bladder cancer was available. Many American plaintiffs who have filed an Actos lawsuit have used the European recall as support for their criticism of Takeda, complaining that the company should have taken the French and German actions more seriously.

FDA Hesitates on Recall, Strengthens Actos Label Warning

Despite the fact that many patients have had to file an Actos lawsuit after developing Actos bladder cancer, the FDA has yet to act definitely against the drug. Instead of mandating a recall, the FDA recently updated the drug’s prescribing information to warn physicians that patients who have suffered bladder cancer should not take Actos. The drug’s label also now warns patients to seek immediate attention if they experience symptoms of Actos bladder cancer, like blood in the urine or pain during urination.

For many frustrated patients who have filed an Actos lawsuit after developing Actos bladder cancer, the FDA has not acted quickly enough to ensure the safety of American citizens. The French  recall and German suspension of the drug are evidence enough for many of the significant risk of Actos bladder cancer. As Takeda begins to face each Actos lawsuit in court, the company may be forced to take action, but until then, Actos remains on the market in America.