التفاصيل البيبلوغرافية
| العنوان: |
The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012 |
| المؤلفون: |
Zhou EH, Seymour S, Goulding MR, Kang EM, Major JM, Iyasu S |
| المصدر: |
Journal of Asthma and Allergy, Vol Volume10, Pp 67-74 (2017) |
| بيانات النشر: |
Dove Medical Press, 2017. |
| سنة النشر: |
2017 |
| المجموعة: |
LCC:Immunologic diseases. Allergy |
| مصطلحات موضوعية: |
LABA, dispensing pattern, U.S. FDA, regulatory activities, Immunologic diseases. Allergy, RC581-607 |
| الوصف: |
Esther H Zhou,1 Sally Seymour,2 Margie R Goulding,1 Elizabeth M Kang,1 Jacqueline M Major,1 Solomon Iyasu1 1Division of Epidemiology, Office of Surveillance and Epidemiology, 2Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA Background: Emerging safety issues associated with long-acting beta2-agonist (LABA) have led to multiple regulatory activities by the US Food and Drug Administration (FDA) since 2003, including Drug Safety Communications (DSCs) in 2010. These DSCs had three specific recommendations for the safe use of LABA products in adult asthma treatment. Methods: We examined the initiation of LABA-containing products for adult asthma treatment using an intermittent time series approach in a claims database from 2003 to 2012. We assessed the alignment of dispensing patterns with the following 2010 FDA recommendations: 1) contraindicated use of single-ingredient (SI)-LABA without an asthma controller medication (ACM); 2) a LABA should only be used when asthma is not adequately controlled on inhaled corticosteroids (ICSs) or ACM; and 3) step-down asthma therapy (e.g., discontinue LABA) when asthma control is achieved. Results: There were 477,922 adults (18–64 years old) dispensed a new LABA during 2003–2012. Among LABA initiators, patients who initiated an SI-LABA and who did “not” have an ACM dispensed on the same date decreased from >9% in 2003 (the initial labeling change) to |
| نوع الوثيقة: |
article |
| وصف الملف: |
electronic resource |
| اللغة: |
English |
| تدمد: |
1178-6965 |
| Relation: |
https://www.dovepress.com/the-us-food-and-drug-administrationrsquos-drug-safety-recommendations--peer-reviewed-article-JAA; https://doaj.org/toc/1178-6965 |
| URL الوصول: |
https://doaj.org/article/3d7370039129419a8aa4dcdd413b5b93 |
| رقم الانضمام: |
edsdoj.3d7370039129419a8aa4dcdd413b5b93 |
| قاعدة البيانات: |
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