Potential Safety Signals and Their Significance

Powers A, Cook G. — Mon, 09 Jan 2012 00:00:00 GMT

In 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 present and is aimed to maintain the FDA's postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The content of this database is dependent on the voluntary reporting from both health care professionals and consumers and is mandatory for pharmaceutical manufacturers. For the purpose of this research letter, potential safety signals are potential signals of serious risks and new safety information identified by the FDA through the surveillance of the AERS database. The process of posting potential safety signal quarterly reports generated from AERS started in the first quarter of 2008 by the FDA. The FDA indicates that the identified potential safety signals do not denote a causal relationship between the drug and the listed risk. In addition, the FDA emphasizes that prescribers and consumers should not take any action. This creates confusion for both health care providers and consumers because a potential safety signal has been identified on the FDA's Web site, calling into question the meaningfulness of the listed potential safety signal. Should health care professionals and consumers be cautious if a potential safety signal is present on the FDA's Web site?

JAMA Internal Medicine: Drug Interactions Topic Collection

Potential Safety Signals and Their Significance