Actos Side Effects

Bladder cancer and heart failure are among serious Actos side effects potentially associated with the Type 2 diabetes medication.

Legal Reviews for Those Harmed by Actos

Bernstein Liebhard LLP provides free legal reviews to alleged victims of Actos side effects, including bladder cancer. To discuss your case with a member of our legal staff, please call (888) 994-5118.

What is Actos?

Actos is an oral medication indicated to treat Type 2 diabetes. Launched in 1998, the drug was a blockbuster for Takeda Pharmaceuticals, and at one point accounted for a quarter of the company’s sales.

Clinical trials for Actos involved more than 10,000 patients. A variety of mild to severe side effects were reported during the studies, ranging from headaches to heart failure. Those most commonly associated with Actos include:

  • Upper respiratory infection
  • Headache
  • Sinus infection/irritation
  • Muscle pain
  • Tooth pain and dental problems
  • Sore throat
  • Allergic reactions such as skin rashes, hives, itching or swelling of the face, lips or tongue
  • Fever, chills
  • Unusual fatigue
  • Hypoglycemia (low blood sugar)

Actos and Bladder Cancer

During clinical trials for Actos, drug-induced tumors were observed in the urinary bladders of male and female rats. In June 2011, the U.S. Food & Drug Administration (FDA) warned that long-term use of Actos for a year or more had been linked to a 40% increased risk for bladder cancer. The agency’s warning followed d the release of five-year interim results from 10-year study conducted by Takeda Pharmaceuticals. New information regarding a possible increased risk of bladder cancer would be added to the “Warning and Precautions” section of the Actos label, as well as other diabetes medications that contain pioglitazone.

That same month, regulators in France and Germany suspended sales of Actos because of its potential association with bladder cancer. Takeda would eventually recall Actos from those markets.

Thousands of people have filed Actos lawsuits in the U.S. after allegedly developing bladder cancer related to its use. In September 2015, Takeda finalized a $2.37 billion settlement that would resolve many of those claims. Read More

Actos and Heart Failure

According to a Black Box Warning on the Actos label, the drug has been linked to congestive heart failure in patients with and without pre-exisiting heart problems. Weight gain and water retention (edema) are both Actos side effects, and are know to contribute to heart problems.

Actos and Macular Edema

Macular Edema, a type of swelling that occurs at the back of the eye, has been reported in Actos patients. Type 2 diabetics should undergo regular eye exams, and those taking Actos should contact their doctor if they experience any acute vision problems.

Actos and Bone Fractures

One Actos study suggested that women taking the drug were more likely to experience bone fractures, especially fractures involving the hands, upper arms and feet. During follow-up, 5.1 of Actos users experienced such fractures compared to 2.5 percent for placebo users.

Actos and Liver Failure

Actos has been associated with reports of fatal and non-fatal liver failure. Periodic monitoring of liver enzymes is recommended. Actos should be stopped in patients who show signs of jaundice.

Actos and Kidney Disease

Research published in PLoS One in 2014 suggested that Actos side effects might include chronic kidney disease. The study involved 35,000 people with diabetes, and revealed that 8% of those taking Actos developed the condition.

Legal Help for Victims of Actos Side Effects

Bernstein Liebhard LLP provides expert legal representation to those who have been harmed by prescription medications, including Actos. To arrange for your free legal review, please call (888) 994-5118.

  1. FDA (2011) “Actos Prescribing Information”
  2. FDA (2011) “FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer”
  3. CBS News (2011) “Actos banned in Europe after diabetes drug tied to cancer”
  4. FiercePharma (2015) “Takeda gets enough takers to complete $2.3B Actos settlement”
  5. FDA (2007) “Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk”
  6. PLoS One (2014) “The Association of Pioglitazone and Urinary Tract Disease in Type 2 Diabetic Taiwanese: Bladder Cancer and Chronic Kidney Disease”
Last Modified: July 1, 2016

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