FDA actions

FDA actions

The news isn't much better for fenofibrate. The FDA has issued a safety communication for the cholesterol lowering medication stating that the drug may not lower the risk of major cardiovascular events based on data from the ACCORD Lipid trial. ACCORD (similar in design to AIM-HIGH) evaluated the efficacy and safety of fenofibrate plus simvastatin vs simvastatin alone in patients with type 2 diabetes. There was no significant difference in the risk of experiencing a major adverse cardiac event between the two groups, and women may have even experienced an increase in the risk for major adverse cardiac events with combination therapy vs simvastatin alone. The FDA is requiring the manufacturer of Trilipix brand fenofibric acid to conduct a clinical trial to evaluate the cardiovascular effects of the drug in patients at high risk for cardiovascular disease who are already taking statins (www.fda.gov/Drugs/DrugSafety/ucm278837.htm).

The FDA has approved a new formulation of zolpidem for treatment of insomnia in patients who wake up in the middle of the night and have difficulty returning to sleep. Zolpidem, originally marketed as Ambien and now available as a generic, is a short-acting hypnotic. The new product is a lower dose sublingual formulation that comes in a 1.75 mg dosage recommended for women and 3.5 mg for men. The lower dose for women is recommended because women clear the drug more slowly than men. It can be used if the patient has at least 4 hours of bedtime remaining. Zolpidem sublingual is marketed by Transcept Pharmaceuticals as Intermezzo.