The FDA said an analysis of data collected during a 5-year period from an ongoing 1o-year observational study conducted by the manufacturer, Takeda Pharmaceuticals North American Inc in San Diego showed overall there was no significant association between use of Actos and increased risk of bladder cancer among diabetes mellitus patients. Apparently, those who used Actos were 20 percent more likely to be diagnosed with the cancer, but the increase was deemed statistically insignificant.
The FDA acknowledged the risk of bladder cancer was found significantly higher among those who had either been using Actos for more than two years or had had a highest accumulative dose of this medication.
The health regulator did not say how higher the risk it was among those patients at risk. Instead, it advised doctors should continue following the current recommendations to prescribe Actos and patients would take the drug as prescribed. If they have any concern or worry, they should talk to a medical professional.
At this time, the agency stressed it has not concluded that it is Actos that caused the increase in the risk of bladder cancer among patients who either used the drug for more than 2 years or those whose accumulative intakes of this drug over the years were the highest. It will inform the public of further information on the safety issue when it has become available, probably within a few months.
Based on the information released by the FDA, it is possible that Actos increases the risk of bladder cancer among the diabetes mellitus patients, a health observer suggested.
The FDA cited preclicnical carcinogenicity studies of Actos saying male rats receiving doses of the drug that were equivalent to what diabetes patients receive were at higher risk of bladder cancer. Also, two 3-year controlled clinical studies of Actos showed patients who used Actos were at higher risk of bladder cancer compared to those who used other medications.
The FDA said these data have been included in the Actos drug label as precautions. But it does not mean that Actos as the cause increases the risk of this malignancy.
The health observer, who did not want to be named, cautioned the patients included in the analysis took Actos for a period between 0.2 and 8.5 years. He said although the overall risk was not significant higher in the whole population, the risk differed among individuals. That is why those who had taken the Actos for more than 2 years and those who had highest accumulative doses were at greater risk.
Actos was approved July 15, 1999 as an adjunct to diet and exercise to control blood sugar in adults with type 2 diabetes mellitus. Studies suggest Actos does not increase as much heart risk as its competitor known as rosiglitazone or Avandia, which is made by GlaxoSmithKline. Rosiglitazone was found twice as likely to suffer heart attack as Actos.
Red meat, processed meat, soft drinks, eggs, fruit juice, and arsenic in drinking water have been associated with an increased risk of type 2 diabetes mellitus, while coffee consumption, brown rice, vitamin d, exercise, plant-based diet, omega-3 fatty acids, garlic, fish, turmeric, micronutrients like selenium, vitamin e, vanadium, and chromium, soy products, Mediterranean diet, L-carnitine, and black tea may help reduce the risk or actually prevent the disease.