Wednesday, September 22, 2010

US FDA is reviewing preliminary safety information about Drug Actos (pioglitazone) for possible association with risk of bladder cancer.

The United States. F D A on 17-SEP-2010 has made an announcement that they are reviewing preliminary safety information about Drug Actos (pioglitazone) a anti diabetes drug .

FDA is reviewing safety as it is reported that the drug may be associated with risk of bladder cancer, after receiving preliminary results from a long-term observational study designed to evaluate the use of this drug.

FDA states in their press release that the preliminary results are based up on ongoing, 10-year observational study by the pharmaceutical manufacturer, Takeda Pharmaceuticals, an North America Inc., San Diego. and the data collected is five-year data .

Early results did not showed any association of Drug Actos (pioglitazone) exposure and and risk of bladder cancer. How ever it is being evaluated by FDA for possibilities association with risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug .

FDA stated in their press release that they have not yet concluded that Actos increases the risk of bladder cancer.

Information about Actos (pioglitazone)

It is a anti diabetic drug belonging to the class thiazolidinedione (TZD) drugs known as peroxisome proliferator-activated receptor (PPAR) agonists.Drug Actos (pioglitazone) currently is in use to control blood sugar level in patients suffering from Type II diabetes mellitus.

Pioglitazone stimulates the nuclear receptor peroxisome proliferator-activated receptor gamma (PPAR-γ) , PPAR-α , there by enhancing the trascription of insuline sensitive genes responsible for glucose and lipid metabolism taking place in adipose and musclular tissue and in liver , as a result pioglitazone reduces the resistance of insulin in periferal tissue and liver. Drug Avandia (rosiglitazone) is the other only one drug that also belongs to class of drug peroxisome proliferator-activated receptor (PPAR) agonists.

FDA stated in press release that they don’t have any clinical information associating other drug Avandia with bladder cancer in patients receiving that drug.

As US FDA has not concluded the result of review of the association between use of Actos (pioglitazone) and increased risk of bladder cancer. FDA has asked patients to talk to their health care professional, and they should not stop taking the drug unless asked to do so by their health care professional.

No comments: