Takeda’s popular diabetes medication Actos (pioglitazone) has recently been linked in studies to an increased risk for bladder cancer in patients who take the drug for an extended period of time.
Free Confidential Lawsuit Evaluation:If you or a loved one has been diagnosed with cancer after taking Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
How does Actos work?
Manufactured and marketed by Takeda Pharmaceuticals, Actos (pioglitazone hydrochloride) is an FDA-approved prescription medication used to control blood sugar levels in patients with Type II diabetes. Actos belongs to a class of drugs known as thiazolidinediones (TZDs) that are designed to work by keeping blood glucose levels within a target range by making the body more sensitive to insulin. This essentially means that Actos helps your body use its natural insulin more efficiently, which, in turn, helps to lower blood sugar and keep it under control. Research has shown that by getting blood sugar levels under control with Actos, it may be possible to decrease the chances of developing diabetes complications such as heart disease, diabetic retinopathy, and diabetic neuropathy.
For individuals with Type II diabetes, the body is able to produce some insulin, but not enough. The diabetic’s cells have become resistant to the effects of insulin and are unable to respond to it. This is a condition that is referred to as ‘insulin resistance.‘ When muscle becomes insulin resistant, the body is unable to utilize glucose effectively. When this occurs, the body responds by telling the pancreas to produce extra insulin. The extra insulin releases the cells and forces them to take the insulin from the bloodstream. When the liver becomes insulin resistant, it overproduces glucose, which makes the level of glucose rise in the bloodstream.
Actos is designed to reduce insulin resistance, fasting insulin levels and blood glucose. Along with a healthy diet and regular exercise, Actos works by helping the body use naturally produced or artificially administered insulin to use glucose as fuel and reduce the harmful buildup of the substance in the blood. The medication is sold under the brand names Actos, as well as Actoplus Met, Duetact, and the generic name, pioglitazone.
Actos & Bladder Cancer
Unfortunately, mounting research and numerous case studies have linked Actos to an increased risk for bladder cancer in patients taking the drug for an extended period of time. In August 2011, the FDA issued a press release stating that it was requiring Takeda to change Actos labels to include a warning that individuals taking the medication for longer than one year may be at risk of developing bladder cancer. According to the press release:
“This safety information is based on FDA’s review of data from a five-year interim analysis of an ongoing, ten-year epidemiological study. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.”
The FDA is advising physicians not to prescribe Actos to patients with a history of bladder cancer or in individuals with uninvestigated macroscopic haematuria, and to assess the bladder cancer risk prior to beginning a regimen of Actos. Taking age-related factors into consideration (especially bladder cancer, fractures and heart failure), the risks vs. rewards of taking Actos should be weighed carefully before initiating and during treatment of the elderly. Prescribing doctors should review the treatment of patients on Actos regularly to ensure that they are deriving sufficient benefits from the drug.
Signs & Symptoms
Bladder cancer begins when normal cells in the bladder begin to change and grow uncontrollably, resulting in a mass called a tumor. A tumor can be benign (noncancerous) or malignant, meaning that it can spread to other parts of the body. Potential signs and symptoms of bladder cancer may include:
- blood or red color in urine
- urgent need to urinate
- pain while urinating (dysuria)
- urinating small amounts frequently
- frequent urinary tract infections
Symptoms that may be indicative of more advanced bladder cancer include:
- lower back pain
- swelling in the lower legs
- a growth in the pelvis near the bladder (pelvic mass)
- weight loss
- bone pain or pain in the rectal, anal or pelvic area
Actos Cancer Lawsuits on the Rise
Takeda is currently facing hundreds of lawsuits around the country over Actos and reports of bladder cancer side effects. The complaints allege that Actos caused bladder cancer – in some cases fatal – in patients who took the medication for an extended period of more than one year. In June 2011, the company halted sales of the drug in Germany and France in response to intense pressure from European regulators.
The new safety questions will play heavily in determining Actos’s future, particularly since the drug’s patent expires next year. It now appears that Actos won’t make nearly as much money as expected until the patent runs out, and prospects for similar experimental drugs that were supposed to succeed Actos have been dampened.
Interested in learning more? Please click here if you’d like addition information about Actos and cancer from Schmidt & Clark, LLP.
Do I Have an Actos Cancer Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. We are handling individual litigation nationwide and currently accepting new bladder cancer cases in all 50 states.
Free Confidential Case Evaluation: Again, if you got bladder cancer after taking Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.