Actos Information - Frequently Asked Questions

What is Actos?

Actos is a once-daily oral drug prescribed to treat high blood sugar in people like you with type 2 diabetes. It can be prescribed by itself or combined with other diabetes medications, such as metformin and glimepride.

What is the active ingredient in Actos?

The active ingredient in Actos is pioglitazone hydrochloride, which helps sensitize your body's cells to insulin so they can absorb the sugar in your bloodstream and use it for energy. Actos also reduces the amount of sugar your liver releases into the bloodstream. (See Actos medication background.)

Who makes Actos?

Actos is manufactured by Takeda Pharmaceuticals, a Japanese company with a global business that includes the United States and Europe. (See Actos medication background.)

What is type 2 diabetes?

When you have type 2 diabetes, your body either doesn't make enough of the hormone insulin, or can't effectively use the insulin it does make. When this occurs, your cells can't absorb the sugar from your bloodstream that they need for fuel. Unused, the sugar builds up in your bloodstream and can cause heart attacks, circulation problems, strokes, kidney damage and blindness. (See Actos.)

Does Actos have serious side effects?

The most serious Actos side effects are:

  • Heart failure, particularly among older patients and patients also taking insulin
  • Bladder cancer, among Actos users taking the highest doses for more than 12 months
  • Bone fractures of the hands, feet and upper arms among women
  • Liver failure or damage
  • Swelling of the macula behind the eye
  • Swelling of the hands, feet, legs
  • Hypoglycemia, when used with insulin
  • Anemia
  • Ovulation

Will Actos increase my risk of having bladder cancer?

While the exact cause of bladder cancer is unknown, it has been associated with a number of potential risk factors, including chemical exposure, smoking and the prolonged use of the diabetes drug Actos. (See Bladder cancer causes.)

Although drugmaker Takeda Pharmaceuticals says Actos-containing medicines are safe, the Food and Drug Administration warned June 15, 2011 that early results from a 10-year study begun in 2002 found long-term Actos users taking the highest doses had a 40 percent increased cancer risk. (See FDA warning.)

What are the common bladder symptoms of bladder cancer?

The National Institutes of Health lists the following bladder cancer symptoms, including,

  • Blood in the urine
  • Frequent urination
  • Pain while urinating
  • Urine leakage
  • Abdominal pain
  • Back pain

Has there been an Actos recall?

The Food and Drug Administration, the agency that oversees drug safety in the United States, hasn't recalled any Actos-containing drugs because of side effects. It has asked Takeda Pharmaceuticals to more prominently list the increased risk of bladder cancer and heart failure on the package insert. (See FDA warning.) France has stopped all Actos sales and Germany has stopped Actos use in new patients. Other European Union countries have limited Actos for use as a last resort – and with extensive monitoring. (See Actos recall.)

Has anyone sued Takeda Pharmaceuticals because of the bladder cancer risk associated with Actos?

Yes. News reports quote Takeda Pharmaceuticals lawyers as saying 54 lawsuits have been brought against the company in federal court since July 2011, but dozens more have been filed since then. In December 2011, a federal judge consolidated these cases before one judge in Lafayette, La.

Would I be eligible for compensation?

It's possible you may be entitled to Actos compensation for your losses, including medical expenses, loss of income, pain and anguish and wrongful-death damages for your family. You can find out if you have a claim against Takeda Pharmaceuticals by filling out a free case evaluation form now.

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