Pioglitazone, manufactured under the brand name Actos is a leading medication prescribed to treat diabetes mellitus type 2, a metabolic disorder in which the body cannot properly process insulin. Insulin is a hormone naturally produced in the body, necessary to remove excess glucose and regulate metabolism of carbohydrates and fat. Excessive glucose levels can become toxic and result in organ failure, circulatory disorders and cognitive dysfunction.Following extensive investigations conducted by the United States Food and Drug Administration, known as the FDA, into the diabetes medication Avandia, Actos was aggressively promoted to medical professionals as the new wonder drug for the treatment of type 2 diabetes. Actos has come under intense scrutiny due to reports of an increased risk of bladder cancer among patients who have taken the medication for over one year. Despite known risks associated with the development of congestive heart failure, Actos has become the leading diabetes medication in the United States, with sales in 2008 skyrocketing to $2.4 billion.
The FDA issued an initial safety warning statement in June 2011 concerning the risk of bladder cancer from taking Actos. A study of diabetes patients undergoing treatment with Actos revealed that those who had been prescribed the medication for more than one year had a 40 percent higher risk of developing bladder cancer than those undergoing treatment with other medications. Although the FDA has not issued an official recall, a decision was made in August 2011 to include information regarding the potential risks of bladder cancer in the Warnings section of the prescribing label for Actos. A subsequent FDA warning was issued in September 2011.
Following an extensive epidemiological study, the French Agency for the Safety of Health Products withdrew pioglitazone from the market in June 2011 due to reported cases of bladder cancer. The German Federal Institute for Drugs and Medical Devices followed suit, advising physicians not to prescribe the medication until further cancer risk investigations had been conducted.
Bladder cancer originates in cells lining the bladder, known as transitional cells. Bladder cancer can spread to adjacent organs including the rectum, ureters, uterus, vagina and prostate. It can spread to lymph nodes in the pelvic area, resulting in infiltration into bones, liver and lungs. Symptoms indicative of bladder cancer include blood in the urine, urinary retention or incontinence, painful urination, abdominal pain, fatigue and weight loss.
Treatment for bladder cancer depends on size of the tumor and stage of the cancer. Stage I treatment involves surgical removal of the tumor followed by a course of chemotherapy. Stage II and III treatment involves surgical removal of the bladder and surrounding lymph nodes, followed by aggressive chemotherapy and radiation. Most people diagnosed with Stage IV bladder cancer cannot be cured and are maintained on chemotherapy and immunotherapy agents to prevent further spread of the cancer.
Numerous Actos lawsuits have been filed against Takeda Pharmaceutical Co., Ltd. due to the linkage of pioglitazone to bladder cancer. Class action lawsuits allege development of Actos bladder cancer as a result of the manufacturer’s failure to adequately research risk factors associated with the drug. It is further alleged that despite the company’s knowledge of the risks of bladder cancer, it failed to issue adequate warnings to health care professionals and consumers.
An article recently published by the Associated Press revealed that despite new and ongoing research linking the use of pioglitazone with the development of bladder cancer, sales of the medication have been allowed to continue.