Why Is Oral Phenylephrine on the Market After Compelling Evidence of Its Ineffectiveness as a Decongestant?-Reference-Cited by-同舟云学术

Why Is Oral Phenylephrine on the Market After Compelling Evidence of Its Ineffectiveness as a Decongestant?

Published:2022-03-25 Issue:11 Volume:56 Page:1275-1278
ISSN:1060-0280
Container-title:Annals of Pharmacotherapy
language:en
Short-container-title:Ann Pharmacother

Author:

Hatton Randy C.¹^ORCID,Hendeles Leslie²³

Affiliation:

1. Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Fernandina Beach, FL, USA

2. Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA

3. Pediatric Pulmonary Division, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, USA

Abstract

Ineffective over-the-counter (OTC) drugs should be removed from the US market. Despite solid research showing that oral phenylephrine is ineffective as a decongestant, the US Food and Drug Administration has failed to respond to a 2015 citizen’s petition to remove it from the OTC nasal decongestant monograph. Other examples of scientifically proven ineffective OTC medications include guaifenesin as an expectorant, dextromethorphan as a cough suppressant, and chlorpheniramine for cold symptoms.

Publisher

SAGE Publications

Subject

Pharmacology (medical)

Link

http://journals.sagepub.com/doi/pdf/10.1177/10600280221081526

Reference22 articles.

1. Over-The-Counter (OTC) Drug Monograph Process. United States Food and Drug Administration. Current as of September 3, 2020. Accessed December 3, 2021. https://www.fda.gov/drugs/over-counter-otc-drug-monograph-process.

2. Over-The-Counter (OTC) Drug Review—OTC Monograph Reform in the Cares Act. US Food and Drug Administration. Current as of November 23, 2021. Accessed December 5, 2021. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act.

3. US Food and Drug Administration. Rulemaking History for OTC Nasal Decongestant Drug Products. Published March 6, 2017. Accessed February 1, 2022. https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-nasal-decongestant-drug-products.

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