FDA Posts Names of Prescription Drugs Being Investigated for Potential Safety Problems

FDA officials have stated that they will begin publishing a quarterly a list of drugs being investigated for potential safety risks. The list which is available on the FDA Web site by clicking here: http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm 

names the drug and the nature of the related "adverse event" but does not address the severity or the number of such events reported. Appearing on the list does not mean a drug has been found to be unsafe. Only drugs submitted to the agency's Adverse Events Reporting System (AERS) will be included on the list. The agency also investigates drugs based on data from clinical trials and other studies, but such drugs will not appear on the list. Although the list is intended to provide consumers and health care professionals with advance information on FDA investigations, many experts -- including some inside the agency -- have raised concerns that the system could harm patients by causing unneeded alarm.