The Changing Face of Drug-induced Adrenal Insufficiency in the Food and Drug Administration Adverse Event Reporting System.
J Clin Endocrinol Metab
; 107(8): e3107-e3114, 2022 07 14.
Article
en En
| MEDLINE
| ID: mdl-35704533
ABSTRACT
CONTEXT Adrenal insufficiency (AI) is a life-threatening condition complicating heterogeneous disorders across various disciplines, with challenging diagnosis and a notable drug-induced component. OBJECTIVE:
This work aimed to describe the spectrum of drug-induced AI through adverse drug event reports received by the US Food and Drug Administration (FDA).METHODS:
A retrospective disproportionality analysis reporting trends of drug-induced AI was conducted on the FDA Adverse Event Reporting System (FAERS) (>â 15â 000â 000 reports since 2004). AE reports were extracted from FAERS over the past 2 decades. Interventions included cases containing any of the preferred terms in the Medical Dictionary for Regulatory Activities describing AI, and signals of disproportionate reporting for drugs recorded in 10 or more cases as primary suspect.RESULTS:
We identified 8496 cases of AI 97.5% serious, 41.1% requiring hospitalization. AI showed an exponential increase throughout the years, with 5282 (62.2%) cases in 2015 to 2020. We identified 56 compounds associated with substantial disproportionality glucocorticoids (Nâ =â 1971), monoclonal antibodies (Nâ =â 1644, of which Nâ =â 1330 were associated with immune checkpoint inhibitors-ICIs), hormone therapy (Nâ =â 291), anti-infectives (Nâ =â 252), drugs for hypercortisolism or adrenocortical cancer diagnosis/treatment (Nâ =â 169), and protein kinase inhibitors (Nâ =â 138). Cases of AI by glucocorticoids were stable in each 5-year period (22%-27%), whereas those by monoclonal antibodies, largely ICIs, peaked from 13% in 2010 to 2015 to 33% in 2015 to 2020.CONCLUSION:
We provide a comprehensive insight into the evolution of drug-induced AI, highlighting the heterogeneous spectrum of culprit drug classes and the emerging increased reporting of ICIs. We claim for the urgent identification of predictive factors for drug-induced AI, and the establishment of screening and educational protocols for patients and caregivers.Palabras clave
Texto completo:
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Bases de datos:
MEDLINE
Asunto principal:
Insuficiencia Suprarrenal
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
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Antineoplásicos Inmunológicos
Tipo de estudio:
Diagnostic_studies
/
Guideline
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Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
J Clin Endocrinol Metab
Año:
2022
Tipo del documento:
Article
País de afiliación:
Italia