What is Actos?

Pharmaceutical Liability Lawyers

Actos is a prescription medication taken by individuals with type 2 diabetes (diabetes mellitus) to help control their blood sugar (glucose) levels. Generically known as pioglitazone, the medication is sold as a single-ingredient drug under the name Actos or in combination with other diabetes medications, such as metformin, sulfonylurea or insulin. The combination drugs have been sold as Actoplus met, Actoplus met XR, and Duetact.

Actos and Increased Cardiovascular Risk

Actos is in a class of drugs known as peroxisome proliferator-activated receptor (PPAR) agonists. The only other drug in this class is Avandia (rosiglitazone). The federal Food and Drug Administration significantly restricted the prescribing of Avandia in 2010 due to the drug's link to increased risk of cardiovascular injury, including heart attacks and strokes.

Like Avandia, Actos has been shown to be associated with an increased risk of heart problems. Accordingly, the FDA has required a warning on the drug's label to alert patients of this risk.

Actos Linked to Bladder Cancer

The federal Food and Drug Administration has issued a warning to all diabetics who take Actos (generically known as pioglitazone), a popular drug for treatment of type 2 diabetes mellitus, that continued use of the medication for more than 12 months increases the risk of bladder cancer.

Bladder cancer is a difficult diagnosis to receive. The available treatment options can be devastating and the chance of a recurrence of cancer is high. It is important to know the risk factors associated with bladder cancer. Persons with known risk factors need to watch for symptoms of bladder cancer because early detection of bladder cancer can significantly affects a person's chance of recovery.

A 10-year evaluation of diabetic patients' treatment and outcomes was conducted on approximately 200,000 individuals participating in the Kaiser Permanente Northern California health plan. The FDA analyzed interim data from that study and found that diabetics who took Actos for more than 12 months had a 40% greater chance of developing bladder cancer - a significant increase in risk.

Common Symptoms

The most common symptom of bladder cancer is blood in the urine. The amount of blood found varies. It may be sufficient to discolor the urine, making it brown or red. In others, the presence of blood can be detected only through laboratory tests.

The following symptoms also are common:

  • Urgent need to urinate
  • Frequent urination
  • Feeling a need to urinate without result
  • Needing to strain to urinate
  • Feeling pain during urination

Final analysis of the data obtained from the diabetic study group has not been completed; however, the data to date is clear that use of Actos for more than one year is associated with a significant increase in risk for bladder cancer. All diabetic patients should discuss this risk with their physician and be diligent in monitoring their health for signs of bladder cancer. Anyone who develops bladder cancer while taking Actos or a combination drug that includes Actos should act promptly to secure their rights.

If you are experiencing symptoms of bladder cancer while taking Actos, contact Fibich, Leebron, Copeland & Briggs to schedule a complimentary case evaluation.

Stages of Cancer and Treatment Options

Which treatment option is available depends on the stage of the cancer. Tests are performed to determine whether the cancer is limited to the bladder or if it has spread. Generally, the cancer stages are divided as follows:

  • Stage 0 - Cancer cells found only on the surface of the lining of the bladder.
  • Stage 1 - Cancer penetrates into the lining of the bladder.
  • Stage 2 - Cancer has progressed further into the muscle layer of the bladder.
  • Stage 3 - Cancer moves beyond the bladder to other tissue and organs, such as the prostate, uterus or vagina.
  • Stage 4 - Cancer is found either in (1) the pelvis or abdomen or (2) a lymph node or distant part of the body such as the liver, lungs or bones.

Common treatment plans include surgery, chemotherapy, and radiation treatment. Surgery can be limited to removal of cancerous cells or complete removal of the bladder and nearby tissues and organs.

By stage, the 5-year survival rate is as follows:

  • Stage 0 is 98%
  • Stage 1 is 88%
  • Stage 2 is 63%
  • Stage 3 is 46%
  • Stage is 15%

Fibich, Leebron, Copeland & Briggs can be reached at (713) 489-6566.