Table 1.

Characteristics of new and incremental BBWs.^a

BBW component category	BBW component value	All new BBWs & major updates: No. (% of new and major updates)	New BBW: No. (% of new)	Major update: No. (% of major updates)	Minor update: No. (% of minor updates)c
Warning typeb	Death	34 (51)	20 (63)	14 (40)	n/a
	Cardiovascular	18 (27)	9 (28)	9 (26)	n/a
	Oncologic	6 (9)	2 (6)	4 (11)	n/a
	Fetal toxicity	2 (3)	0 (0)	2 (6)	n/a
	Hepatotoxic	8 (12)	5 (16)	3 (9)	n/a
	Neuropsychiatric	2 (3)	2 (6)	0 (0)	n/a
	Neurologic	4 (6)	3 (9)	1 (3)	n/a
	Vision Loss/Ophthalmologic	2 (3)	1 (3)	1 (3)	n/a
	Metabolic	2 (3)	1 (3)	1 (3)	n/a
	Renal	4 (6)	3 (9)	1 (3)	n/a
	Musculoskeletal	2 (3)	1 (3)	1 (3)	n/a
	Hematologic	2 (3)	2 (6)	0 (0)	n/a
	Infectious	6 (9)	4 (13)	2 (6)	n/a
	Pulmonary	3 (4)	1 (3)	2 (6)	n/a
	Gastrointestinal	1 (1)	1 (3)	0 (0)	n/a
	Infusion Reaction/Anaphylactic	4 (6)	2 (6)	2 (6)	n/a
	Cutaneous	1 (1)	1 (3)	0 (0)	n/a
Patient population	Total	67 (100)	32 (100)	35 (100)	n/a
	General	31 (46)	19 (59)	12 (34)	n/a
	Specific population	19 (28)	4 (13)	15 (43)	n/a
	General with high risk in specific population	17 (25)	9 (28)	8 (23)	n/a
Pediatric		8 (12)	3 (9)	5 (14)	3 (7)
Class warning		15 (22)	7 (22)	8 (23)	8 (18)
Drug-Drug interaction		3 (4)	2 (6)	1 (3)	5 (11)
Monitoring		27 (40)	10 (31)	17 (49)	2 (5)
ETASU REMS	Total	67 (100)	32 (100)	35 (100)	44 (100)
	BBW accompanied by ETASU REMS	3 (4)	0 (0)	3 (9)	0 (0)
	ETASU REMS already in place	4 (6)	0 (0)	4 (11)	4 (9)
	No ETASU REMS before or immediately after BBW	59 (88)	32 (100)	27 (77)	40 (91)
	BBW accompanied by removal of ETASU REMS	1 (1)	0 (0)	1 (3)	0 (0)

BBW: Black Box Warning; ETASU: Elements To Assure Safe Use; REMS: Risk Evaluation & Mitigation Strategy.

^aSums of percentages may not equal the total percentage due to rounding.

^bNew BBWs and major BBW updates were classified under all applicable warnings types.

^cBBW updates that included new or substantially updated information about a risk or patient population were classified as major updates; therefore, warning type and patient population were not classified for minor updates.