ResultsA total of 5366 medication error reports were identified during the time period. Of these, 3660 (68.2%) were classified, from a regulatory perspective (21 CFR 314.80), as serious (causing death, a threat to life, hospitalization, disability, congenital anomaly or requiring intervention to prevent permanent impairment or damage). Death resulted in 528 (9.8%) of these cases. We excluded 59 reports as duplicates or intentional overdoses. A total of 469 deaths were caused by medication errors. These are sorted by the year they were reported to FDA in Figure 1. Of these, 84 reports (18%) were directly reported to FDA by consumers and health care providers via the MedWatch program. Manufacturers reported 385 reports (82%) to FDA. The increase in reports during calendar year 1998 is probably reflective of FDA's decision to capture all medication error reports within one database (AERS) and no longer support a related database, the Drug Quality Reporting System. Figure.Reports of deaths per year received by FDA.Two hundred and seven deaths were assessed as related to an error, 219 as possibly related, and 43 as unrelated.

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Objective: To identify and analyze postmarketing case reports of elevated blood pressure (BP) associated with erenumab use. Methods: A retrospective analysis of postmarketing (spontaneous) case reports of erenumab-associated elevated BP submitted to the FDA Adverse Event Reporting System from May 17, 2018 through April 30, 2020. A case of elevated BP was defined as (a) an initiation of a pharmacological intervention or emergency department visit or hospitalization for emergent de novo or worsening of preexisting hypertension, or (b) BP measurement of ≥140 mm Hg systolic or ≥90 mm Hg diastolic with or without baseline BP measurement reported. Reports of elevated BP associated with erenumab use were analyzed for baseline and demographic information, latency, drug-event causal association, and clinical outcome. Results: Sixty-one cases of elevated BP were identified, 86% (49/57) were women and the median age was 56 [range 24-88] years. Forty-one cases were associated with a serious outcome per regulatory criteria, including seven that specified hospitalization. No case reported an outcome of death. The median systolic BP increase was 39 (interquartile range (IQR) 32, 59) mm Hg and median diastolic BP increase was 28 (IQR 18, 41) mm Hg. A total of 27/61 (44%) cases reported treatment for elevated BP (i.e., pharmacologic intervention or emergency department visit/hospitalization). Elevated BP occurred most frequently (28/61, 46%) within a week of the first dose of erenumab. Nineteen cases (19/61, 31%) reported a history of preexisting hypertension. Conclusions: This case series suggest an association between elevated BP and use of erenumab. In light of our findings, the erenumab (Aimovig) prescribing information was amended to include hypertension in the Warnings and Precautions section.

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