Harmful Drugs Law

Drug Actos Under Fire for Allegedly Increasing Risk of Bladder Cancer

Diabetes is a group of diseases characterized by high blood glucose levels that result from defects in the body’s ability to produce and/or use insulin. According to the American Diabetes Association, there are 25.8 million people, or 8.3% of the population, who have diabetes.

There are generally two types of diabetes. In type 1, the body does not produce insulin. Generally, this is diagnosed in children and young adults. Type 2 diabetes is the most common form. With type 2, either the body does not produce enough insulin or the cells ignore the insulin.  Many people believe that type 2 diabetes is curable through diet and weight loss. While that opinion has yet to be proven, drugs are commonly used to treat type 2 diabetes.

Two common drugs are rosiglitazone (which has been established to associate with heart disease) and pioglitazone. Under FDA restrictions from 2010, rosiglitazone is only to be used in patients who have failed therapy with pioglitazone. A manufacturer, Takeda Pharmaceutical Industries Limited (“Takeda”), created the drug Actos, a pioglitazone medication, which is now under fire.

Back in June 2011, the FDA released its interim review of an ongoing epidemiological study regarding Actos. Five-year data showed that patients with the longest exposure to and the highest cumulative dose of the drug were at greater risk of bladder cancer.

The five-year analysis concluded that patients on the drug, for more than a year, had a 40% increased risk of bladder cancer compared with those who never took it. The significance of bladder cancer increased further after two years. The FDA said “therapy longer than a year was associated with 27.5 excess cases of bladder cancer per 100,000 person-years of follow-up, compared with never using the drug.”

Back in summer 2011, Germany and France banned use of the drug.

Takeda stressed that the interim data showed short-term use of the drug was not associated with an increased risk of bladder cancer and that “use for more than two years was weakly associated with increased risk.”

At the time of the July 2011 FDA statement, the 10-year epidemiological study on Actos was yet to be completed. The study was set to be completed this year.

Sue Kirkman, MD, vice president of medical affairs for the American Diabetes Association said just prior to the FDA’s recent statement that evidence of bladder cancer risk with pioglitazone has been “conflicting, and its hard to know whether this is a real problem or not…. [the] organizations main concern is that patients might stop taking their medication after hearing the news about the increased risk rather than talking to their doctors first.”

Recently, however, the Journal for the National Cancer Institute supported the link between bladder cancer and long-term use of Actos. Also, this past summer, the Canadian Medical Journal Association, published a study showing that data from over 2.6 million patients demonstrated that the risk of bladder cancer increased 22 percent with the use of Actos. It is also reported by the Institute for Safe Medication Practices’ that the FDA received over 1,000 reports of bladder cancer since last January.

Despite carrying a black-box warning that the FDA requires for drugs that may pose serious or life-threatening risks, around 10 million people worldwide have taken Actos. If are currently taking Actos it is recommended that you speak with your doctor prior to coming off of the medication.

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