Evidence map›Paper›PMID 40434620›Full record

ArticleClinical drug investigation2025

Trends in US Pediatric Unintentional Nonprescription Cold and Cough, Analgesic and Antipyretic Drug Exposure Cases amid the COVID-19 Pandemic.

Sara Karami, Christian Angelo I Ventura, Ellen Pinnow, Jody Green, Ajoa Asonye, Ibrahim T Ibrahim, Lynda McCulley, Gerald J Dal Pan, Esther H Zhou

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical drug investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Sara Karami *Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0001-7658-7977
Christian Angelo I Ventura *Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.
Ellen PinnowOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0002-9183-4662
Jody GreenOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.
Ajoa AsonyeOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.
Ibrahim T IbrahimOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.
Lynda McCulleyOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0003-0935-3876
Gerald J Dal PanOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.ORCID http://orcid.org/0000-0003-4874-5864
Esther H ZhouOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA. Esther.Zhou@fda.hhs.gov.ORCID http://orcid.org/0000-0003-4608-6850

Funding

Oak Ridge Associated Universities DE-SC0014664
6 · The paper itself

Abstract

backgroundThe coronavirus disease 2019 (COVID-19) pandemic dramatically impacted healthcare systems.

objectiveWe assessed monthly unintentional pediatric (< 18 years) exposure case rate trends involving selected nonprescription cold and cough (CC), as well as analgesic and antipyretic (AA) drugs, before and during the COVID-19 pandemic, using the National Poison Data System (extracted August 2023).

methodsWe included dextromethorphan, guaifenesin, phenylephrine, and pseudoephedrine CC drugs, and acetaminophen, naproxen, ibuprofen, and acetylsalicylic acid AA drugs; statins served as a control. We performed descriptive analyses involving single-product unintentional pediatric exposure cases overall, by sex, and by age. We performed interrupted time series (ITS) analyses, modeling associations between the pandemic's immediate and sustained effects, adjusting for population and seasonality.

resultsOverall, apart from the control, acetylsalicylic acid, and naproxen drugs, monthly unintentional single-product exposure case rates decreased sharply at the pandemic's onset. In ITS analyses, rates decreased most notably for cases involving children < 6 years old, where unintentional-general and unintentional-therapeutic error case rates statistically significantly fell by 1.8-12.6 cases per million population at the pandemic's onset. During the pandemic, case rates gradually increased to pre-pandemic levels within 1.5 years. For cases involving children < 6 years old, these exposure case rates statistically significantly rose by 0.1-0.6 cases per million population per month compared with pre-pandemic levels. Monthly case rate patterns for cases 6-12 years old mirrored those of cases < 6 years old, with less pronounced level and trend changes.

conclusionsThese findings underscore the need for continuously adapting public health strategies to ensure drug safety during prolonged periods of public health emergencies.

Indexed as

AnalgesicsAntipyreticsCommon ColdCoughCOVID-19Nonprescription DrugsAdolescentChildChild, PreschoolFemaleHumansInfantMalePandemicsSARS-CoV-2United StatesAnalgesicsAntipyreticsNonprescription Drugs

Identifiers

PMID40434620
PMCPMC12255545

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.