The U.S. Food and Drug Administration relies on the Adverse Event Reporting system to flag safety issues and identify pharmaceuticals or therapeutic biological products (such as blood products), for further epidemiological study. It may ultimately prompt regulatory responses such as drug labeling changes, letters to health care professionals, or market withdrawals.
Journalists who have used this data recommend using it to guide reporting on consumer medical issues, the FDA or the pharmaceutical industry. This data is current as of December 2003. For more information, see www.ire.org/datalibrary/databases/AERS. To order the data, call 573-884-7711.