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Actos is the brand name for the diabetes medication pioglitazone hydrochloride. Manufactured by Takeda Pharmaceuticals and In 2010, Actos was the 10th most commonly prescribed drug in the U.S. and had sales of approximately $4.8 billion. About 2.3 million prescriptions were written for Actosin 2010, and the drug was widely used worldwide. Marketed by Eli Lilly, Actos is a prescription medication that is administered to Type 2 diabetes patients to improve glucose (blood sugar) control.

Unfortunately, many of the patients who were prescribed Actos discovered that the diabetes medication had dangerous side effects. A significant increase in the risk of bladder cancer is the most serious side effect, but Actos can also cause liver problems, bone fractures, hypoglycemia, ovulation in premenopausal women without regular monthly periods and a host of other health issues. These side effects can be dangerous, or even deadly.

At Roberts & Roberts, our experienced dangerous drug attorneys are assisting patients who have suffered dangerous side effects from Actos.

Actos Dangers

As required, Takeda Pharmaceuticals conducted a study on Actos prior to its release in 1999. The study revealed that rats dosed with Actos had an increased risk of bladder cancer. Takeda allegedly did not provide complete information about these findings to any health regulators, including the FDA, and information about potential dangers was buried in a “Patient Package Insert” that largely went unread.

An aggressive marketing campaign resulted in Actos being widely prescribed, with patients unaware that the medication they were taking could cause bladder cancer or other dangerous side effects.

Although Takeda Pharmaceuticals did not initially disclose the link between Actos and bladder cancer, the link soon became apparent as patients began to experience complications.

Researchers also began to take note of the dangers. One study in the British Medical Journal, for example, indicated that Actos doubled the risk of bladder cancer.Other research indicated that long-term Actos users had a 40 percent greater chance of developing bladder cancer. An epidemiological study conducted in France also affirmed the connection.

In response to the problems that were being uncovered, the FDA released a Safety Communication in June 2011, alerting the public that prolonged Actos use could increase the risk of bladder cancer. The consequences of the drug have a cumulative effect, with those who have taken Actos for a year or more at the greatest risk of developing bladder cancer. The FDA warning was based on, among other things, the results of an ongoing five-year study conducted by Takeda Pharmaceuticals confirming that long-term use of the drug was dangerous.

Other countries took even stronger action, with both France and Germany banning the sale of Actos and other pioglitazone drugs in June 2011. The bans in Europe occurred within days of the FDA’s communication warning patients of the risks.

Declining to ban the drug, the FDA imposed a new mandate in August 2011. The Actos label now must contain a warning that the drug shouldn’t be used in patients who currently have bladder cancer or who have a history of developing bladder cancer.

The FDA also cautions that patients should inform their physician right away if they develop bladder cancer symptoms, including:

  • Bloody urine or a red color in urine
  • Pain while urinating
  • An urgent need to urinate
  • Lower abdomen pain
  • Back pain.

A detailed medication guide is available from the FDA website which explains what patients should know about the potential complications of Actos, including the risks of bladder cancer.

Other Actos Side Effects

In addition to an increased risk of bladder cancer, there are also other potential side effects of Actos.

These side effects are explained in the FDA’s medication guide and include:

  • Liver problems — Symptoms can include stomach pain, vomiting, nausea, unexplained fatigue, dark urine and yellowing of the eyes or skin. You should inform your doctor right away if you experience these complications.
  • Broken bones/bone fractures — Women are most susceptible to this complication. The broken bone normally occurs in the upper arm, foot or hand.
  • Hypoglycemia — This refers to low blood sugar. Symptoms include hunger, shakiness or dizziness.
  • Macular edema — The lay term for this condition is diabetic eye disease with swelling in the back of the eye. Symptoms of this condition include a change of vision.

Common and less severe side effects include sore throat, sinus infection, headache, cold symptoms and muscle pain.

Is Actos Responsible for Harm?

Many drugs have some side effects and potential risks. However, patients need to be informed of the dangers. When a drug carries an unexpected risk or there are especially dangerous side effects –such as an increased risk of bladder cancer — then the drug manufacturer could be held liable for damage caused by their medication.

This means that if you or a loved one took Actos and developed bladder cancer or other serious side effects, you may be able to take legal action to hold the drug manufacturer responsible. Already, several thousand patients have filed Actos lawsuits in order to obtain compensation for illnesses and injuries caused by the drug.

Have You Suffered Actos Side Effects? Talk to Our Dangerous Drug Lawyers

If you or a loved one has suffered serious side effects from taking Actos, you could be entitled to compensation.

The dangerous drug attorneys at Roberts & Roberts are currently investigating claims related to Actos. For a free, confidential review of your claim, call us today at 903-597-6000 or 903-597-6000 or contact us online. The call costs you nothing … It could mean everything.


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You have nothing to lose by letting our attorneys advise you of your options. For a free, immediate attorney review of your case, contact us using the form below or call us at (903) 597-6000.

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