Study Indicates Diabetes Treatment May Carry Higher Risk Than Previously Believed

According to a recently released study by BMJ (www.bmj.com), formerly known as the British Medical Journal, the widely prescribed diabetes drug Actos has been linked to increased cases of bladder cancer. Actos, manufactured by Takeda Pharmaceuticals, is used in the treatment and management of Type 2 diabetes. Actos is also known generically as pioglitazone.

actosThe findings underscore the issues that have been plaguing the drug in the marketplace for some time. Troubles began in June 2011, when the FDA issued a warning to consumers regarding a potential increase in the risk for developing bladder cancer. This warning was indicated for patients using Actos for more than 12 months. Some European countries, including France and Germany, made the decision at that time to pull the drug completely from the market. Currently in the United States, Actos carries a black box warning, the strongest warning issued by the FDA, indicating that the drug has potentially dangerous side effects.

The new BMJ study analyzed the medical records from 1988 to 2009 of more than 115,000 British patients who had been prescribed anti-diabetic drugs. The conclusion that there is an increased risk for bladder cancer seems most applicable to those using the drug for more than 24 months or in higher doses – more 28,000 mg over the course of treatment.

Although the drug carries a previous warning about its risk for bladder cancer, the popular pill is still widely prescribed in the United States for diabetes treatment. According to a report from the IMS Institute for Healthcare Informatics (www.imshealth.com), a pharmaceutical market intelligence firm, in 2010 Actos was ninth on the list of the top ten best-selling drugs in the United States. In 2010, Americans spent $3.5 billion on Actos.

The American Cancer Society (www.cancer.org) reports that over 73,000 people will be diagnosed with bladder cancer in the United States this year, with over 14,000 eventually dying from the disease in the same period. Treatment options can include surgery, chemotherapy and radiation treatment.

In light of this new information, physicians and their patients will now need to determine if the benefits of Actos outweigh the risks for each individual case.

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