What is Actos? Actos (pioglitazone) is an anti-diabetic drug (of the thiazolidinedione-type, also called “glitazones”) that should be taken in conjunction with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes (also known as non-insulin-dependent diabetes). It works by helping to restore the body’s proper response to insulin, which in turn will then lower blood sugar.
How does Actos work?
Diabetics have a deficiency or absence of insulin, which is a hormone the pancreas produces. Insulin is the main hormone responsible for controlling blood sugar. In the case of type 2 diabetes, the pancreas does not produce sufficient insulin, hence in type 2 diabetes blood sugar levels can rise too high.
Actos helps to lower blood glucose levels by increasing the sensitivity of liver, fat and muscle cells to insulin. This enables the cells to remove glucose from the blood more effectively. The drug also reduces the amount of glucose produced by the liver, and preserves the functioning of the cells in the pancreas that produce insulin.
The overall effect of Actos is, therefore, to help the body control its own blood sugar levels and prevent them from rising too high.
Which company manufactures Actos?
Actos is manufactured by Takeda Pharmaceuticals, which is the U.S. subsidiary of Takeda Pharmaceutical Company Limited, Japan’s largest drug company.
What risks are associated with Actos?
The U.S. Food and Drug Administration has warned that patients who use Actos for more than one year face an increased risk of developing bladder cancer. Actos’s safety label was updated in June 2011 to reflect this risk. The warning was based on the results of an ongoing 10-year study by Kaiser Permanente. The updated drug label also offered healthcare professionals two recommendations:
- Don’t use Actos (pioglitazone) in patients with active bladder cancer.
- Exercise caution when using Actos to treat patients with a history of bladder cancer.
Studies have continued to suggest that Actos can increase the risk of bladder cancer. For instance, the May 31, 2012 issue of the British Medical Journal found that Actos users were twice as likely to develop bladder cancer after two years. In July 3, 2012, the Canadian Medical Association Journal found that patients taking the medication were 22 percent more likely to get bladder cancer.
The agency also added a black box warning to Actos in 2007 about the drug’s risk of causing congestive heart failure.
Does the FDA plan to recall Actos?
Court documents disclosed that Takeda officials had to have known that clinical studies were indicating the existence of links between Actos and bladder cancer as early as 2005, but the company still failed to issue a warning. Six years would pass before it finally did note there were some risks linked to its diabetes drug. In 2011, health officials in France and Germany pulled Actos from the market after the drug was linked to bladder cancer. Still, the FDA has not announced recall plans.
The agency has, however, prompted a revise of the drug’s packaging to include warnings of bladder cancer. The warning label on the packaging was modified for Actos, Actoplus Met, Actoplus Met XR, and Duetact.
What are some of the warning signs of bladder cancer?
According to the Mayo Clinic, bladder cancer signs and symptoms may include:
- Blood in urine (hematuria) — urine may appear dark yellow, bright red or cola colored. Or urine may appear normal, but blood may be detected in a microscopic examination of the urine
- Frequent urination
- Painful urination
- Back pain
- Pelvic pain
If you are experiencing these symptoms, please contact your doctor for an evaluation of your risk of bladder cancer.
I believe my bladder cancer is related to my Actos usage, can I file a lawsuit?
If you have not been diagnosed with bladder cancer but believe you are experiencing symptoms of the disease, seek medical attention.
If you have been diagnosed with bladder cancer and take, or have taken, Actos, we would be pleased to discuss the potential for filing a claim with you.
What if I was diagnosed with bladder cancer a long time ago?
You still may have a viable claim, and should contact us.
Are there any upfront fees that I will be charged?
No. Case reviews are free and we only get paid if you win.