Several recent studies have shown a much stronger link between Actos (pioglitazone) and bladder cancer than was indicated during clinical trials. In June 2011, the U.S. Food and Drug Administration (FDA) published a “Drug Safety Communication,” indicating that based on dose and duration of use, there exists a 40 percent increased risk of developing Actos bladder cancer.
During clinical trials, there was an indication that it could cause bladder cancer. However, most patients and their doctors were not aware of the possible link between Actos and bladder cancer. Since that time, there have been a number of studies linking the drug to bladder cancer, including one that showed an 83 percent increased risk for bladder cancer among Actos users.
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Studies Linking Actos and Bladder Cancer
Three primary studies are most cited regarding Actos bladder cancer. The foremost is a 10-year study conducted by Kaiser Permanente Northern California. Sponsored by Takeda, the manufacturer of Actos, and required by the FDA, it started in 2002 after preclinical trials indicated an increase in urinary bladder tumors in rats. Although final results have not been released, a five-year interim analysis indicated a 40 percent increased risk of bladder cancer in patients who took Actos for more than 12 months. That analysis was the basis for the FDA’s 2011 label and insert requirements regarding Actos bladder cancer.
Unlike other warnings about severe side effects, the update was to the Warnings and Precautions section and not to the Contraindication section. There was not an update to the drug’s black-box label indicating the risk of Actos bladder cancer.
The most widely known international study researching Actos bladder cancer was a three-year study by the French Medicines Agency from 2006 to 2009 that examined 1.5 million patients. It found a statistically significant indication that patients taking pioglitazone, the active ingredient in Actos, are at a greater risk of developing bladder cancer. Researchers stated their findings were very similar to those of the KPNC study.
In June 2011, the French Medicines Agency announced that it had suspended the use of Actos. Germany quickly followed suit, except it limited suspension to all new cases. In August 2011, Takeda formally withdrew Actos from those markets. In April 2011, the American Diabetes Association published a report that reviewed adverse drug reports filed with the FDA. Researchers stated they “found a definite signal for bladder cancer associated with pioglitazone use.”
One of the most recent studies on Actos and bladder cancer was published in the May 2012 issue of the British Medical Journal. Researchers studied 115,727 patients and discovered that Actos use increased the risk of bladder cancer by 83 percent. They also revealed that the risk increases with long-term use of Actos.
What is Bladder Cancer?
Bladder cancer is one of the most common types of cancer in the United States, with an estimated 74,000 people receiving diagnoses in 2012 and another 15,000 patients dying from bladder cancer last year. Medical professionals predict an increase in the number of bladder cancer cases in the coming years.
Cigarette smoking and chemical exposure are among the leading causes of bladder cancer, the second-most common urological cancer in adults. Bladder cancer is more common among men than women, and afflicts more Caucasians than African-Americans. It is also known for its high recurrence rate.
But for patients diagnosed with bladder cancer, the silver lining comes in the form of statistics and new medical procedures:
- About 80 percent of bladder cancer patients are diagnosed in the earliest stages.
- The overall five-year survival rate is nearly 80 percent.
- Innovative techniques allow an increasing number of patients to keep their bladder rather than having it removed.
Bladder Cancer Causes
Among the risk factors for bladder cancer are advanced age, chronic bladder infections and treatment with certain types of medications. Those medications include cyclophosphamide, a common chemotherapy drug, and pioglitazone, the active ingredient in the type 2 diabetes drug Actos.
Researchers say that because the leading cause of bladder cancer is smoking, it is one of the most preventable types of cancer. Studies show that cigarette smoking raises the risk for bladder cancer fourfold.
The medical theory about bladder cancer is that it is caused by an increased concentration of toxic chemicals in urine, which exposes the bladder to those chemicals. And that, over time, this exposure causes cancer. Bladder cancer is described as a signature disease of Actos, pointing to the theory of toxic exposure being a primary cause of the disease.
Some occupations pose a stronger risk of daily exposure to workplace chemicals, which can lead to bladder cancer. Among them are:
- Medical workers
- Truck drivers
There are also some lesser-known causes, including arsenic and chlorine compounds found in drinking water, and sexually transmitted diseases, such as gonorrhea and human papilloma virus (HPV).
Symptoms of Bladder Cancer
Symptoms of bladder cancer develop quietly in a majority of people with the disease. Hematuria, also known as bloody urine, is typically the first sign of the disease. But because this symptom is usually painless and fleeting, most patients are either unaware of it or ignore it. Although the blood could be visible, it is most often undetectable unless under a microscope.
For this reason, many patients don’t learn of their diagnosis until after a urine analysis. Frequent bladder infections, frequent urination, back pain and painful urination are among the warning signs. While these are less common, they should not be ignored.
Diagnosing Bladder Cancer
Because of the stealthy nature of bladder cancer, most patients are taken by surprise by a bladder cancer diagnosis. It often comes after testing for recurrent urinary tract infections (UTIs) or during a routine medical visit.
Once tumor markers are found in the urine, doctors order a series of other tests. These include an intravenous pyelogram (IVP), the standard imaging test for bladder cancer. Through this test, physicians can view the bladder and surrounding organs for evidence of cancer. Doctors also use CT scans, MRI scans and bone scans, as well as ultrasounds, for a more complete look at the bladder.
For a closer look at the inside of the bladder, doctors may perform a bladder biopsy. This is done with a long, flexible device called a cystoscope that is inserted into the bladder through the urethra. Small tissue samples are removed for laboratory examination.
Once bladder cancer is diagnosed, oncologists will stage the cancer using the tumor, node and metastases (TNM) system. With this, medical professionals can determine the extent of the cancer and the best course of treatment.
Bladder Cancer Treatment
Treatment depends on the stage, or progress, of the disease.
Stage 0 through 1 treatments (non-muscle invasive):
- Transurethral Resection (TUR or TURBT) – With the use of a cystoscope, surgeons are able to cauterize, or burn away, the destructive cancer cells.
- Segmental cystectomy – In some early-stage patients, surgeons will remove a portion of the diseased bladder. The remaining bladder is sewn together.
- Chemotherapy and immunotherapy – To ensure the cancer is killed, sometimes oncologists will order several rounds of chemotherapy or immunotherapy to impede the early-stage disease.
Stage II, III and IV treatments (muscle invasive)
- Radical cystectomy – In this procedure, a surgeon removes the entire diseased bladder and replaces it with one of several urinary diversions. These include creating a new bladder from the intestines or creating a new urinary elimination system.
- Chemotherapy and immunotherapy – Unless the patient is sickly or elderly, oncologists will prescribe either or both of these treatments to further destroy this spreading disease.
- Clinical trials – Many oncologists will recommend that advanced-stage patients seek clinical trials for new and inventive ways to battle bladder cancer.
Despite the best efforts of medical professionals, bladder cancer is known to reoccur in most cases. For this reason, medical professionals recommend that patients have check-ups every three months for the first three years after diagnosis and then every year thereafter.
Actos Bladder Cancer Lawsuits
It is estimated that Takeda could face more than 10,000 Actos bladder cancer lawsuits. Takeda is being sued in federal court and in state courts. With the June 2011 announcement by the FDA that it was requiring a bladder cancer warning be placed on the Actos label and insert, the FDA gave legitimacy to many former Actos users’ claims that the drug caused them to develop bladder cancer.
Those claims had received limited response from the courts, Takeda and the FDA. Since the FDA announcement, there has been a marked increase in the filing of Actos lawsuits and also in inquiries about the possibility of filing a lawsuit. With several hundred federal cases pending, both Takeda and plaintiff attorneys filed to move all pending Actos lawsuits to one district court. On Dec. 30, 2011, the U.S. Judicial Panel on Multidistrict Litigation in Georgia consolidated all federal Actos bladder cancer lawsuits to the U.S. District Court for the Western District of Louisiana. The federal caseload now exceeds 1,200, and the state caseload is close to 2,000.