Details:

Alternative Title:
Pediatrics
Personal Author:
Hampton, Lee M. ; Nguyen, Duc B. ; Edwards, Jonathan R. ; Budnitz, Daniel S.
Hampton, Lee M. ; Nguyen, Duc B. ; Edwards, Jonathan R. ; Budnitz, Daniel S. Less -
Description:
BACKGROUND

In October 2007, manufacturers voluntarily withdrew over-the-counter (OTC) infant cough and cold medications (CCMs) from the US market. A year later, manufacturers announced OTC CCM labeling would be revised to warn against OTC CCM use by children aged <4 years. We determined whether emergency department (ED) visits for CCM adverse drug events (ADEs) declined after these interventions.

METHODS

We used National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance data from 2004 to 2011 to estimate the number of ED visits for CCM ADEs before and after each intervention.

RESULTS

Among children aged <2 years, ED visits for CCM ADEs decreased from 4.1% of all ADE ED visits before the market withdrawal to 2.4% of all ADE visits afterward (difference in proportion: –1.7%, 95% confidence interval [CI]: –2.7% to –0.6%). Among children aged 2 to 3 years, ED visits for CCM ADEs decreased from 9.5% of all ADE ED visits before the labeling revision announcement to 6.5% of all ADE visits afterward (difference in proportion: –3.0%, 95% CI: –5.4% to –0.6%). Unsupervised ingestions accounted for 64.3% (95% CI: 51.1% to 77.5%) of CCM ADE ED visits involving children aged <2 years after the withdrawal and 88.8% (95% CI: 83.8% to 93.8%) of visits involving children aged 2 to 3 years after the labeling revision announcement.

CONCLUSIONS

After a voluntary market withdrawal and labeling revision, ED visits for CCM ADEs declined among children aged <2 years and 2 to 3 years relative to ADE ED visits for all drugs. Interventions addressing unsupervised ingestions are needed to reduce CCM ADEs.


Subject:
[+]
Adverse Drug Reaction Reporting Systems
Adverse Events
Antitussive Agents
Article
Child
Child, Preschool
Drug-Related Side Effects And Adverse Reactions
Drug Labeling
Drug Packaging
Drug Safety
Emergency Service, Hospital
Expectorants
Female
Humans
Infant
Infant, Newborn
Male
Medication Errors
Nasal Decongestants
Nonprescription Drugs
Poisoning
Product Withdrawals
Safety-Based Drug Withdrawals
Expectorants
Nonprescription Drugs

Source:
Pediatrics. 132(6):1047-1054.
Pubmed ID:
24218462
Pubmed Central ID:
PMC4696492
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States ; D43 TW001042/TW/FIC NIH HHS/United States
CC999999/Intramural CDC HHS/United States ; D43 TW001042/TW/FIC NIH HHS/United States Less -
Place as Subject:
United States
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:5e6636975934389cce787ccdcad8c4001ea2a186b4470f7e4769c1b579ec051a
File Type:

Supporting Files

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