RT Journal
A1 Moore TJ, Singh S, Furberg CD
T1 THe fda and new safety warnings
JF Archives of Internal Medicine
JO Archives of Internal Medicine
YR 2012
FD January 9
VO 172
IS 1
SP 78
OP 80
DO 10.1001/archinternmed.2011.618
UL http://dx.doi.org/10.1001/archinternmed.2011.618
AB 
In response to postmarket drug safety surveillance and research data, the US Food and Drug Administration (FDA) and drug manufacturer may take 1 of 2 types of action. In extreme cases the FDA may remove a drug from the market. More often the product label or package insert is revised to reflect newly discovered risks. The most clinically significant new information is added to 1 of 3 legally defined sections of the prescribing information1: (1) a boxed warning (information that is essential to be considered when prescribing the drug); (2) a contraindication (clinical situations when a drug's risks clearly outweigh its benefits); and (3) a warning (adverse reactions with reasonable evidence of a causal association, reactions that may require discontinuation, or reactions that interfere with a laboratory test).