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Impact of the voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers†

  1. Wendy Klein-Schwartz1,*,
  2. John David Sorkin2,
  3. Suzanne Doyon1

Article first published online: 8 JUN 2010

DOI: 10.1002/pds.1971

Issue

Pharmacoepidemiology and Drug Safety

Pharmacoepidemiology and Drug Safety

Volume 19, Issue 8, pages 819–824, August 2010

Additional Information

How to Cite

Klein-Schwartz, W., Sorkin, J. D. and Doyon, S. (2010), Impact of the voluntary withdrawal of over-the-counter cough and cold medications on pediatric ingestions reported to poison centers. Pharmacoepidem. Drug Safe., 19: 819–824. doi: 10.1002/pds.1971

Author Information

  1. 1

    Maryland Poison Center, University of Maryland School of Pharmacy, Baltimore, MD, USA

  2. 2

    Department of Medicine, Division of Gerontology and Geriatric Medicine, University of Maryland School of Medicine, MD, USA

*220 Arch Street, Room 01-108 Baltimore, MD 21201 410-563-5581, USA.

  1. †

    The authors have no conflicts of interest.

Publication History

  1. Issue published online: 20 JUL 2010
  2. Article first published online: 8 JUN 2010
  3. Manuscript Accepted: 11 MAR 2010
  4. Manuscript Revised: 15 FEB 2010
  5. Manuscript Received: 30 OCT 2009

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Keywords:

  • cough and cold medications;
  • pediatric;
  • poisoning;
  • therapeutic error

Abstract

Purpose

To assess the impact of a voluntary withdrawal of over-the-counter cough and cold medications (OTC CCMs) labeled for children under age 2 years on pediatric ingestions reported to the American Association of Poison Control Centers.

Methods

Trend analysis of OTC CCMs ingestions in children under the age 6 years resulting from therapeutic errors or unintentional poisonings for 27 months before (pre-) and 15 months after (post-) the October 2007 voluntary withdrawal was conducted. The rates and outcome severity were examined.

Results

The mean annual rate of therapeutic errors involving OTC CCMs post-withdrawal, in children less than 2-years of age, 45.2/100 000 (95%CI 30.7–66.6) was 54% of the rate pre-withdrawal, 83.8/100 000 (95%CI 67.6–104.0). The decrease was statistically significant p < 0.02. In this age group, there was no difference in the frequency of severe outcomes resulting from therapeutic errors post-withdrawal. There was no significant difference in unintentional poisoning rates post-withdrawal 82.1/100 000 (66.0–102.2) vs. pre-withdrawal 98.3/100 000 (84.4–114.3) (p < 0.21) in children less than 2-years of age. There were no significant reductions in rates of therapeutic errors and unintentional poisonings in children ages 2–5 years, who were not targeted by the withdrawal.

Conclusions

A significant decrease in annual rates of therapeutic errors in children under 2-years reported to Poison Centers followed the voluntary withdrawal of OTC CCMs for children under age 2-years. Concerns that withdrawal of pediatric medications would paradoxically increase poisonings from parents giving products intended for older age groups to young children are not supported. Copyright © 2010 John Wiley & Sons, Ltd.

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