Sunday, January 15, 2012

Actos® and Bladder Cancer

Recent studies have shown that patients taking the drug Actos for longer than one year may suffer significantly increased risks of developing bladder cancer. The FDA warnings are being issued on the heels of France and Germany banning the use of Actos, and New Zealand also beginning the process of removing Actos from patient use. Takeda Pharmaceuticals, the Japanese corporation who began manufacturing Actos in 1999, is at the midway point in a ten-year study of the drug’s potentially serious side effects. While the five-year data shows no clear evidence of an overall increased risk of bladder cancer, patients who have taken the drug in the highest dosages or for the longest period of time appeared to be at a much greater risk of developing bladder cancer.

Actos is in a class of drugs known as thiazolidinediones, and is the second medication of its class to be associated with serious side effects. Avandia, the sister-drug of Actos, recently had its use severely restricted due to evidence of increased heart attack risk and even death. When metformin alone no longer works well for patients suffering from type 2 diabetes, doctors typically prescribe a drug such as Actos which increases the body’s insulin sensitivity, controlling blood sugar levels in the process. Type 2 diabetes, when left untreated, can potentially lead to serious health effects such as damage to the retina which can lead to blindness, injury to the kidneys, impairment of the nerves which could lead to amputations of limbs and an acceleration of the development of fat plaques on the interior of the arteries which can potentially lead to blood clots, blockages, cardiovascular disease, stroke and a lessening of critical circulation.

Shaped like a balloon, the bladder resides in the lower regions of the abdomen and its primary function is storage for urine. Urine is a liquid waste made by the kidneys when they clean the body’s blood—until it is passed from the body. Bladder cancer typically begins in the cells which line the bladder and risk factors include smoking, certain infections, being male, white and elderly, eating a diet which is high in fats and fried foods, and being exposed to specific carcinogenic chemicals commonly used in hairdressing, textile production, paints and rubber manufacturing. Symptoms of bladder cancer include frequent urination, blood in the urine or pain during urination, and lower back pain. Procedures for determining bladder cancer include CT scans, urinalysis, an internal exam, or a cystoscopy.

The chances of recovering from bladder cancer depends largely on what stage the cancer is in when discovered as well as the patient’s age and overall health status. Treatments include chemotherapy, surgery and radiation. The five-year survival rate for patients with early stage bladder cancer is approximately 85%, however in patients with more advanced bladder cancer who have undergone chemotherapy and/or radiation, the five-year survival rate is only 60-75%. Over 14,000 deaths occur each year from bladder cancers.

Several studies have linked the use of Actos for periods of longer than a year or in higher dosages to as much as a 42% increase in the incidence of bladder cancer. The potential risk of Actos users developing bladder cancer has been known for some time; the FDA’s Adverse Event Reporting System has found that 31 cases of bladder cancer were recorded between 2004 and 2009 in patients being treated with an anti-diabetic drug containing pioglitazone, such as Actos. A study of more than 190,000 patients with Type 2 diabetes who were enrolled in the Kaiser Permanente Northern California health plan showed that while there was not a significant overall increased risk of bladder cancer, those patients who were taking higher doses or were taking Actos for longer than twelve months had as much as a 40% increased chance of developing bladder cancer as compared to patients who had never used the drug. The participants in this study were at least forty years old.

The FDA, citing the results of the study done by Takeda as well as another study done by the French National Health Insurance Plan, simply recommended that physicians avoid prescribing Actos in patients suffering from active bladder cancer or in those with a history of bladder cancer. France apparently looked at the results of the tests a little differently, suspending the use of Actos while Germany recommended that no new patients be started on the drug. The FDA has asked any Actos users who have had adverse events while taking the drug to report those events immediately to the FDA’s MedWatch.

Dr. Joseph Giangola, the medical director of diabetes at Hackensack University Medical Center, remains solid in his belief that the benefits of Actos still outweigh the possible risk of developing bladder cancer. Although Dr. Giangola states he is cautious when prescribing Actos, he reminds that there is essentially no drug currently on the market which can effectively replace Actos to influence insulin resistance. The FDA cautions patients to immediately contact their doctor should they have any symptoms of bladder cancer such as blood or red color in the urine, pain upon urination or pain in the lower back and/or abdomen. Takeda Pharmaceuticals states that it will remain positive about the therapeutic benefits of Actos, while continuing its ten-year study on the potential for Actos to cause bladder cancer.

Author: Sullo & Sullo Attorneys

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