An FDA MedWatch Alert released Thursday, August 21, informed healthcare professionals that the FDA is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytroni and an increased risk of cancer. The SEAS is a clinical trial designed to test whether using Vytorin to lower LDL-cholesterol will reduce the risk of cardiovascular events in individuals with aortic stenosis.
The data from the trial has revealed that a larger percentage of subjects treated with Vytorin were diagnosed and died from all types of cancer combined when compared to a placebo during the five year study.
The FDA is looking into the data. Congress demanded immediate access to the clinical trial data. Of course, if misconduct on the part of the pharmaceutical company is discovered then this will be yet another example of the importance of lawsuits and investigations as one method in assisting to ensure the safety of the American drug supply. Congress is looking into other incidents of pharmaceutical misconduct, most notably associated with the prescription drug Ketek. Other examples of misconduct related to the prescription drugs, Reglan and/or metoclopramide and the side effect, tardive dyskinesia are other examples.