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Black Box Warning

   Also found in: Acronyms, Wikipedia 0.01 sec.
Black Box Warning
A cautionary label for all therapeutic agents and/or products—and relevant literature—that the FDA regards as being hazardous to health if incorrectly administered


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The FDA recently ordered a black box warning to be placed on testosterone gel.
But they voted 14-4 with 3 abstentions against the FDA's proposal to include it in a black box warning in the labels of all antiepileptic drugs (AEDs).
The FDA advisory panel ruled on this black box warning after reviewing data concerning death and other negative heart problems associated with stimulant drug medication use.
 
 
 
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