Over the counter but no longer under the radar - pediatric cough and cold medications
Open accessAbstract
Dr. Joshua Sharfstein, Marisa North, and Dr. Janet Serwint write that, in October, an FDA advisory committee voted in favor of immediate action against the use of cough and cold medications in children under 6. After the meeting, the major manufacturers of these products announced that they would continue to market these preparations for children between 2 and 5 years of age.
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A review by the FDA identified 123 deaths related to the use of cough or cold products in children under six years of age over the past few decades.
“and a review by the FDA identified 123 deaths related to the use of such products in children under six years of age over the past few decades (Sharfstein 2007).”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sharfstein 2007
A report from the US Centers for Disease Control and Prevention identified more than 1500 emergency room visits in 2004 and 2005 for children under two years of age who had been given cough or cold products.
“A report from the US Centers for Disease Control and Prevention identified more than 1500 emergency room visits in 2004 and 2005 for children under two years of age who had been given cough or cold products”
From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Sharfstein 2007
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References 1 · Cited by 158
- Authors
- Sharfstein, J. M., North, M., & Serwint, J. R.
- Affiliations
- Johns Hopkins University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2007-12-06
- Volume
- 357
- Issue
- 23
- Pages
- 2321-2324
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2009961936
- Cited by
- 158
- References
- 1
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 5 · 2023: 1 · 2022: 5 · 2021: 7 · 2020: 5 · 2019: 5 · 2018: 4 · 2017: 9 · 2016: 5 · 2015: 11 · 2014: 6 · 2013: 12 · 2012: 12
- FWCI
- 16.17
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Health Professions › Emergency Medical Services › Pediatric health and respiratory diseases
- Keywords
- over-the-counter drugs, FDA advisory committee, drug regulation, children under 6 years, drug safety, pharmaceutical manufacturers
- MeSH terms
- Antitussive Agents, Child, Child, Preschool, Common Cold, Cough, Decision Trees, Nonprescription Drugs, Expectorants, Histamine H1 Antagonists, Humans, Infant, United States, United States Food and Drug Administration, Nasal Decongestants, Treatment Outcome, Drug Approval, Advisory Committees, Marketing
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