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ACTOS & Bladder Cancer

Popular Diabetes Drug ACTOS May Increase Risk of Bladder Cancer

Actos Video Transcript

When your doctor prescribes you medication, you expect it to help treat your illness and make you better - not to cause other, sometimes more serious, health problems. You trust your doctor, and you trust the pharmaceutical companies who have created these supposedly life-saving drugs. You don't expect to risk your health or your life by taking these drugs.

However, thousands of patients with Type 2 Diabetes may have done just that. Many doctors prescribed these patients with the popular drug Actos, which studies suggest may have increased their risk for bladder cancer and exposed them to the risk of macular edema, congestive heart failure, edema, liver failure, hepatitis, fractures, hypoglycemia, heart attacks or strokes.

Actos, manufactured by Takeda Pharmaceuticals, is a single-ingredient prescription version of pioglitazone that increases the body's sensitivity to insulin, helping to control blood sugar levels in those diagnosed with Type 2 Diabetes. It is also sold in combination with metformin under the brand names Actoplus Met and Actoplus Met RX, and in combination with glimepiride under the brand name Duetact.

"Black Box" Warning

In 2011, the U.S. Food and Drug Administration (FDA) issued its strongest possible warning - a "black box" warning - for Actos after studies revealed an increased risk of bladder cancer for those who took the drug (and others containing pioglitazone) for more than 12 months or had received a high cumulative dose. Patients who took Actos for more than a year had a 40 percent increased risk of developing bladder cancer.

The FDA based its Actos warning on a review of five years of data from an ongoing 10-year study conducted by the manufacturer itself. The results of the Actos study prompted the FDA to issue the following warnings:

  • Actos and other drugs containing pioglitazone may increase the risk of bladder cancer.
  • Actos should not be prescribed to patients who have bladder cancer, and doctors should use caution when prescribing Actos to patients with a history of bladder cancer.
  • Patients should report any side effects to their doctors immediately.

Patients are advised to continue taking Actos unless directed otherwise by their doctor.

Actos Ban

Other studies linking Actos and bladder cancer have prompted a ban on the drug in other countries. In France, an independent database study among patients using Actos found a connection between the drug and bladder cancer. As a result, doctors in France are no longer allowed to prescribe Actos to new patients, and they are counseled to find new treatments for those already receiving Actos. After reviewing the results of that study, Germany also suspended the use of Actos.

The FDA says it is aware of the study in France and will conduct a comprehensive review of the data. It will also continue to evaluate the data from the ongoing Takeda Pharmaceuticals study and will update the public when more information becomes available.

Bladder Cancer & Other Serious Side Effects

Patients who are taking Actos and who experience any of the symptoms of bladder cancer should notify their doctors immediately. Some symptoms of bladder cancer can include:

  • Blood in urine
  • Back or lower abdominal pain
  • Urgent or frequent need to urinate
  • Pain or straining during urination
  • Inability to urinate
  • Bladder infections that are not cleared up by medication

Doctors may also discover a growth or abnormalities that could indicate bladder cancer when performing routine exams, such as an ultrasound or pelvic exam.

Bladder cancer can spread to surrounding tissues and organs, such as the vagina, rectum, uterus, or prostate. It can even spread to the lymph nodes or more distant parts or the body, such as the bones or lungs.

Other serious side effects & symptoms Actos users are exposing themselves to the include:

  • Macular Edema (swelling of the retina, which can lead to blindness)
  • Congestive Heart Failure
  • Edema (fluid retention, especially in the lungs and legs)
  • Liver Failure or Hepatitis
  • Fractures (Female patients especially)
  • Hypoglycemia (low blood sugar)
  • Heart Attacks (or other cardiac complications)
  • Strokes

Actos Bladder Cancer Lawsuits

More than 100 lawsuits were filed earlier this year over the alleged Actos bladder cancer connection, and many more are expected to be filed soon. Thousands of potential plaintiffs are expected to make claims that they were exposed to an increased risk of bladder cancer as a result of taking Actos and that Takeda Pharmaceuticals concealed knowledge of this risk and failed to adequately warn consumers and healthcare providers.

Actos was the best-selling Type 2 Diabetes drug on the market in the U.S. in 2011, according to healthcare information firm IMS Health, and the drug saw $3.4 billion in sales. It accounted for nearly 84 percent of sales among drugs in the same class.

North Carolina Actos Lawsuit Attorney

If you or someone you know took Actos and live in North Carolina, you may be eligible to receive compensation. Our team of dedicated NC products liability lawyers are ready to help you pursue the maximum amount of compensation to which you are entitled under the law. Call the Law Offices of James Scott Farrin for assistance. Call 1-866-844-4262 to reach a representative 24 hours a day, 7 days a week. We have offices in Charlotte, Fayetteville, Goldsboro, Greensboro, Greenville, Henderson, New Bern, Raleigh, Roanoke Rapids, Rocky Mount, Sanford and Wilson.