Cough and cold medication adverse events after market withdrawal and labeling revision.
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.
MSc, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS A-24, Atlanta, GA 30329. lhampton@cdc.gov.
Lee M
LM
Hampton
Duc B
DB
Nguyen
Jonathan R
JR
Edwards
Daniel S
DS
Budnitz
D016907:Adverse Drug Reaction Reporting Systems; D000996:Antitussive Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D005100:Expectorants / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D014663:Nasal Decongestants / Q000009:adverse effects*; D004366:Nonprescription Drugs / Q000009:adverse effects*; D056737:Safety-Based Drug Withdrawals; D014481:United States / Q000453:epidemiology
D000996:Antitussive Agents; D005100:Expectorants; D014663:Nasal Decongestants; D004366:Nonprescription Drugs
adverse events; antitussive agents; drug packaging; drug safety; expectorants; medication errors; nasal decongestants; nonprescription drugs; poisoning; product withdrawals