Assessing the risk of intentional self-harm in montelukast users: an updated Sentinel System analysis using ICD-10 coding-Reference-Cited by-同舟云学术

Assessing the risk of intentional self-harm in montelukast users: an updated Sentinel System analysis using ICD-10 coding

Published:2023-12-08 Issue: Volume: Page:1-10
ISSN:0277-0903
Container-title:Journal of Asthma
language:en
Short-container-title:Journal of Asthma

Author:

Apata Jummai¹,Lyons Jennifer G.²,Bradley Marie C.¹,Ma Yong³,Kempner Maria E.²,Kim Ivone⁴,Eworuke Efe⁵,Pennap Dinci⁵,Mosholder Andrew¹

Affiliation:

1. Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, MD, USA

2. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA

3. Division of Biometrics, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, MD, USA

4. Division of Pharmacovigilance, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, MD, USA

5. Formerly at Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, MD, USA

Funder

Task Order

US Food and Drug Administration

Publisher

Informa UK Limited

Subject

Pulmonary and Respiratory Medicine,Immunology and Allergy,Pediatrics, Perinatology and Child Health

Link

https://www.tandfonline.com/doi/pdf/10.1080/02770903.2023.2293064

Reference33 articles.

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2. Wishart DS Feunang YD Guo AC Lo EJ Marcu A Grant JR et al. DrugBank. [cited 2022 Jan 28]. Montelukast. Available from: https://go.drugbank.com/drugs/DB00471.

3. Center for Drug Evaluation and Research [CDER]. Drug safety information for healthcare professionals - updated information on leukotriene inhibitors: montelukast (marketed as singulair) Zafirlukast (marketed as Accolate) and Zileuton (marketed as Zyflo and Zyflo CR) [Internet]. Center for Drug Evaluation and Research; [cited 2022 Feb 14]. Available from: https://wayback.archive-it.org/7993/20170404172438/https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm.

4. Center for Drug Evaluation and Research [CDER]. FDA. FDA; 2020. [cited 2022 Jan 27]. FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug.

5. A Boxed Warning for Montelukast: The FDA Perspective