Difference between revisions of "Black Box Warning"
(Created page with "A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evid...") |
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Latest revision as of 13:57, 23 April 2017
A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug. It is basically a warning with a black box around it, hence the name. Having the black box around the warning means that an adverse reaction to the drug may lead to death or serious injury