TABLE 1.

Characteristics of 101 FDA Black Box Warnings Issued Between January 2008 and June 2015

Black Box Warning Characteristics	Black Box Warnings N = 101a n (%)
	Classification
New BBW	35 (35)
Major update to preexisting BBW	66 (65)
Patient population affected
General	42 (42)
Specific population	30 (30)
General population with higher risk in specific population	29 (29)
Class warning	47 (47)
REMS
BBW accompanied by ETASU REMS or ETASU REMS already in place	17 (17)
No ETASU REMS before or in association with BBW	84 (83)

^aSums of percentages may not equal 100% due to rounding. BBW = black box warning; ETASU = Elements to Assure Safe Use; FDA = U.S. Food and Drug Administration; REMS = Risk Evaluation and Mitigation Strategies.