Trends in Erythropoiesis‐stimulating agent use and blood transfusions for chemotherapy‐induced anemia throughout FDA 's risk evaluation and mitigation strategy lifecycle-Reference-Cited by-同舟云学术

Trends in Erythropoiesis‐stimulating agent use and blood transfusions for chemotherapy‐induced anemia throughout FDA 's risk evaluation and mitigation strategy lifecycle

Published:2021-02-22 Issue:5 Volume:30 Page:626-635
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Vega Amarilys¹^ORCID,Zhang Rongmei²,Wong Hui‐Lee¹,Wernecke Michael³,Alexander Michael⁴,Feng Yuhui³,Lo An‐Chi³,Lufkin Bradley⁴,Ryan Qin⁵,Izem Rima²^ORCID,MaCurdy Thomas E.³⁶,Kelman Jeffrey A.⁷,Graham David J.¹

Affiliation:

1. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring Maryland USA

2. Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring Maryland United States

3. Acumen, LLC Burlingame California USA

4. Acumen, LLC Washington District of Columbia USA

5. Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring Maryland USA

6. Department of Economics Stanford University Stanford California USA

7. Centers for Medicare & Medicaid Services Washington District of Columbia USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5202

Reference25 articles.

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2. Amgen Inc.Procrit (epoetin alfa) [package insert]. U.S. Food and Drug Administration. Available fromhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103234s5369lbl.pdf. Revised July 2018. Accessed December 2020.

3. Amgen Inc.Aranesp (darbepoetin alfa) [package insert]. U.S. Food and Drug Administration. Available fromhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103951s5378lbl.pdf. Revised January 2019. Accessed December 2020.

4. Centers for Medicare & Medicare Services.National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions (110.21). Available fromhttps://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDid=322&ncdver=1. Accessed December 2020.

5. U.S. Food & Drug Administration.Information for Epogen/Procrit (Epoetin alfa). U.S. Food and Drug Administration. Available from:https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm541173.htm. Accessed December 2020.

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