Another study has found evidence that <"http://www.yourlawyer.com/topics/overview/actos">Actos may be associated with an increased risk of bladder cancer. According to a Reuters report, the study, which involved a review of adverse events reported to the U.S. Food and Drug Administration (FDA) database , suggested “disproportionate risk” of bladder cancer associated with Actos, in comparison with other anti-diabetics.
Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the US, according to the FDA. The rate of occurrence is thought to be higher in diabetics.
This new five year study (2004-2009) that looked at half million reactions to various diabetes medications, 138 people developed bladder cancer. A fifth of those occurred in Actos patients.
“Disproportion is indicative of possible risk,” study author Dr. Elisabetta Poluzzi of the University of Bologna in Italy told Reuters, “not of an actual risk.” She said that her study’s findings indicated that the issue of Actos and bladder cancer needs further study.
The label for Actos already contains information about bladder cancer risk in the â€œPrecautions â€“ Carcinogenesis, Mutagenesis, Impairment of Fertilityâ€ section. Studies in animals prior to the marketing of Actos showed an increase in bladder tumors in male rats exposed to the levels used in humans.
Last September, we reported that the FDA had decided to begin a safety review of Actos, after preliminary results of a study indicated an increased risk of bladder cancer. According to the agency, that study showed an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.
While the FDA continues its Actos review, healthcare professionals have been advised to continue to follow the recommendations in the drug label when prescribing Actos. Patients should continue taking Actos unless told otherwise by their healthcare professional, the agency said. Those with concerns about Actos and bladder cancer should speak with their doctor.
Actos was approved in 1999 to improve glycemic control in adults with Type 2 Diabetes. The drug, which is in a class of medications known as thiazolidinediones (TZD), works by reducing insulin resistance. It belongs to the same class of drugs as Avandia, a diabetes medication that has been linked to an increased risk of heart attack and stroke.