Potential safety signals and their significance.

I n 2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act (FDAAA) (121 Stat 962). This Act, by adding subsection (k)(5) to section 505 (21 USC §355), directed the Food and Drug Administration (FDA) to “conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the AERS Website of any new safety information or potential signal of a serious risk identified by AERS within the last quarter.” The AERS contains over 4 million reported adverse events data from 1969 until the pres-