Evaluation of the reported rates of hypersensitivity reactions associated with iron dextran and ferric carboxymaltose based on global data from VigiBase™ and IQVIA™ MIDAS® over a ten-year period from 2008 to 2017

Figures & data

Figure 1. Global sales of intravenous iron products (iron dextran and ferric carboxymaltose) from 2008 to 2017 in million DDDs (IQVIA™ MIDAS® data).

Table 1. Global reported number and rate of hypersensitivity reactions and death with iron dextran (ID) and ferric carboxymaltose (FCM).

	SMQ Anaphylactic reaction Group A–D				Group A				Group B				Group C
	ID		FCM		ID		FCM		ID		FCM		ID		FCM
	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate
2008	105	0.73	69	12.06	32	0.22	27	4.72	59	0.41	28	4.89	34	0.24	61	10.66
2009	121	0.94	126	9.77	46	0.36	48	3.72	59	0.46	33	2.56	45	0.35	100	7.75
2010	72	0.59	138	7.05	25	0.21	58	2.96	36	0.30	46	2.35	21	0.17	104	5.31
2011	125	1.00	115	4.14	44	0.35	33	1.19	55	0.44	36	1.30	50	0.40	87	3.13
2012	88	0.70	151	3.36	20	0.16	45	1.00	42	0.33	46	1.02	38	0.30	106	2.36
2013	77	0.66	261	3.85	13	0.11	59	0.87	38	0.33	79	1.17	41	0.35	201	2.97
2014	94	0.81	315	3.38	21	0.18	44	0.47	38	0.33	89	0.96	43	0.37	213	2.29
2015	96	0.91	418	3.00	15	0.14	55	0.39	43	0.41	129	0.93	49	0.47	295	2.12
2016	91	0.98	525	2.77	16	0.17	70	0.37	43	0.46	169	0.89	50	0.54	365	1.92
2017	59	0.61	670	2.77	18	0.18	75	0.31	22	0.23	189	0.78	26	0.27	467	1.93
2008–2017	928	0.79	2788	3.31	250	0.21	514	0.61	435	0.37	844	1.00	397	0.34	1999	2.37
	Group D				Type I–IV terms				Anaphylactic/anaphylactoid reaction terms				Death
	ID		FCM		ID		FCM		ID		FCM		ID		FCM
	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate	n	Rate
2008	25	0.17	4	0.70	8	0.06	57	9.96	31	0.21	2	0.35	11	0.08	2	0.35
2009	24	0.19	11	0.85	5	0.04	73	5.66	45	0.35	12	0.93	2	0.02	1	0.08
2010	16	0.13	14	0.72	2	0.02	80	4.09	24	0.20	22	1.12	3	0.02	1	0.05
2011	15	0.12	14	0.50	8	0.06	43	1.55	41	0.33	11	0.40	4	0.03	3	0.11
2012	18	0.14	25	0.56	9	0.07	50	1.11	20	0.16	21	0.47	1	0.01	2	0.04
2013	7	0.06	30	0.44	4	0.03	78	1.15	13	0.11	31	0.46	3	0.03	3	0.04
2014	12	0.10	50	0.54	7	0.06	43	0.46	21	0.18	30	0.32	2	0.02	6	0.06
2015	9	0.09	49	0.35	9	0.09	40	0.29	15	0.14	44	0.32	1	0.01	8	0.06
2016	10	0.11	57	0.30	6	0.06	47	0.25	14	0.15	63	0.33	3	0.03	10	0.05
2017	9	0.09	63	0.26	4	0.04	62	0.26	16	0.16	60	0.25	4	0.04	11	0.05
2008–2017	145	0.12	317	0.38	62	0.05	573	0.68	240	0.20	296	0.35	34	0.03	47	0.06

Abbreviations: DDD, defined daily dose; Group A, narrow terms pertaining to hypersensitivity reactions; Group B, broad terms pertaining to respiratory reactions potentially related to hypersensitivity; Group C, broad terms pertaining to skin reactions potentially related to hypersensitivity; Group D, broad terms pertaining to cardiovascular reactions potentially related to hypersensitivity; MedDRA®, Medical Dictionary for Regulatory Activities; n, number of reported adverse drug reactions (VigiBase™ data); rate, number of reported adverse drug reactions per 100,000 DDDs; SMQ, Standardized MedDRA Query.

Figure 2. Global reporting rate of hypersensitivity reactions (SMQ Anaphylactic reaction Group A–D) per 100,000 DDDs of iron dextran and ferric carboxy-maltose (VigiBase™ and IQVIA™ MIDAS® data).

Figure 3. Global reported number, rate, and relative risk of hypersensitivity reactions and death with iron dextran and ferric carboxymaltose from 2008 to 2017. Abbreviations: DDD, defined daily dose; Group A, narrow terms pertaining to hypersensitivity reactions; Group B, broad terms pertaining to respiratory reactions potentially related to hypersensitivity; MedDRA®, Medical Dictionary for Regulatory Activities; n, number of reported adverse drug reactions (VigiBase™ data); rate, number of reported adverse drug reactions per 100,000 DDDs; SMQ, Standardized MedDRA® Query.