RT Journal
A1 Dal Pan GJ, Temple R
T1 Balancing transparency and uncertainty: Comment on “potential safety signals and their significance”
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2012
FD January 9
VO 172
IS 1
SP 74
OP 75
DO 10.1001/archinternmed.2011.546
UL http://dx.doi.org/10.1001/archinternmed.2011.546
AB 
Reports are submitted to the FDA via pharmaceutical companies, or by individuals, and stored in the FDA's Adverse Event Reporting System (AERS) database. The AERS database contains more than 5 million records and in 2010 received more than 600 000 reports.2 The FDA and pharmaceutical industry review these data to look for previously unrecognized ADRs. An initial observation that may represent a new ADR is termed a signal, defined by the World Health Organization as “reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.”3(p94) A signal is an uncertain finding; it can represent a true drug effect but can also reflect the patient's underlying diseases or treatments. Only further analysis can determine if the reported adverse event is likely to be related to the drug. When data support a new ADR, regulatory action is taken, which can range from including the reaction in product labeling, limiting use or other risk minimization efforts, or, rarely, market withdrawal. Severity and frequency of the observed reaction are assessed in relation to the drug's benefits to determine regulatory action.