Question

With Pioglitazone (Actos)r drug recall  What was the reasons for the problem, Why was the problem not identified in the preclinical and clinical trials?

Answer 1

1. With Pioglitazone (Actos)r drug recall  What was the reasons for the problem?

The Pioglitazone (Actos)r drug is an oral diabetes medication is used to control blood sugar level in adults with type 2 diabetes mellitus. The reason for recall was evidence of link to an increased risk of bladder cancer in patient with type 2 diabetes mellitus when taking for more than one year.

Why was the problem not identified in the preclinical and clinical trials?

The problem was not identfied in the preclinical and clinical trials becasue the exposure of the medication Actos was not particularly studies doe carciogenic study and effects that the drug might have on lon term exposure. To detect the problems or increased risk of bladder cancer a lon-term epidemiologic study is required.