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

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

Reference33 articles.

1. CDER-CBER. FDALabel CDER-CBER version [Internet]. [cited 2022 Jan 28]. Available from: http://fdalabel.fda.gov/fdalabel-r/ui/spl-summaries/criteria/98194.

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

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