Q. What did the FDA do when it discovered the link between Actos and bladder cancer in 2011?
A. The FDA issued an immediate revision of the warning labels on the boxed versions of Actos as well as the drug's medication guides and inserts. The FDA also warned doctors to discontinue the use of Actos in patients who actively have bladder cancer or have a family history of the condition. Finally, it encouraged Actos patients to report any unusual urinary tract symptoms such as bloody urine, urinary urgency, painful urination, and back and abdominal pain, as these may be symptoms of bladder cancer.
Q. Did anyone else warn patients against Actos?
A. The FDA's announcement came on the heels of a strong European reaction to the research showing the link between the drug and bladder cancer. On June 10, 2011, the French government banned and recalled Actos. The German government followed suit after an additional review of insurance records showed a clear correlation between patients taking Actos and then being treated for bladder cancer.
Q. What was Actos intended to do??
A. The drug was created as a glucose stabilizing drug for patients with type 2 diabetes.
Q. How was Actos prescribed?
A. It has been prescribed either on its own or part of a combination therapy.
Q. Is Actos known by any other name?
A. Manufactured by Takeda Pharmaceuticals, Actos (Pioglitazone, HCI) is also sold in the United States under the brand names Actoplus Met®, ActoplusMet XR®, and Duetact®.
Q. Is it a popular diabetes medication?
A. Since its FDA approval in 1999, this oral medication became the 10th-best selling drug in the United States. However, the increased risk people developing bladder cancer after taking it for as little as a year has raised legal questions and made doctors unsure about prescribing it.
Q. Besides bladder cancer, what other major side effects can arise from taking Actos?
A. Additional complications include edema and an increased incidence of upper respiratory tract infections. It can also lead to cardiovascular problems, such as heart attacks and congestive heart failure.
Q. Should I be concerned if I am taking Actos?
A. The drug's safety is not a new concern for Actos lawyers and their clients, which raises concerns for doctors and their patients. Those affected by Actos are asking whether adequate research was performed prior to this drug becoming available. They are also in the progress of filing an Actos lawsuit.
Q. What should I do if I have been prescribed Actos?
A. First, review the new Actos warning labels. Then talk to your doctor about whether the drug is right for you.
Q. What if I am an Actos patient and have developed bladder cancer?
A. Please contact us for more information. We can help you get the information you need to make the decision that's best for you. You may even be eligible to be involved in a potential Actos lawsuit or settlement.