One Community’s Perspective on the Withdrawal of Cough and Cold Medications for Infants and Young Children

Abstract

The study goals were to assess, via survey (a) parental knowledge regarding the use of over-the counter (OTC) cough and cold medicines in children younger than the age of 6 years and (b) the effects of the Food and Drug Administration (FDA) recommendations on community pediatricians following voluntary withdrawal of these medications. Of the 179 parents surveyed, approximately 60% had used OTC cough and cold medicines in the past, and many parents indicated an inappropriate dose when asked. Parents who were aware of the recall were significantly less likely to continue use (P < .05). All 33 physicians surveyed were aware of the withdrawal of these medications for children younger than age 2 years and most were aware of consideration to remove these medications for children <6 years old. A total of 15% of physicians reported that FDA considerations were likely to change their practice by reducing or discontinuing use of these medications, whereas 6% would continue recommending these medications.

Keywords

infant child common cold drug therapy cough drug therapy health surveys nonprescription drugs administration and dosage

Get full access to this article

View all access options for this article.

References

Risk with no benefit: the marketing of over-the-counter cough and cold medications for children. The Prescription Project 2007. http://www.pewtrusts.org/uploadedFiles/www.pewtrustsorg/Reports/Medicine_and_Marketing/OTCReport%2010-18-07.pdf. Accessed May 26, 2009.

Vernacchio L. , Kelly JP , Kaufman DW , Mitchell AA Cough and cold medication use by US children, 1999-2006: results from the Slone survey. Pediatrics. 2008;122: e323-e329.

Centers for Disease Control and Prevention. Infant deaths associated with cough and cold medications-two states, 2005. Morb Mortal Wkly Rep. 2007;56:1-4. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm . Accessed January 12, 2009.

Food and Drug Administration. Public Health Advisory: Nonprescription cough and cold medicine use in children, 2007. http://www.fda.gov/cder/drug/advisory/cough_cold.htm. Accessed May 26, 2009.

Funderburk E. , Cox V. Makers of OTC cough and cold medicines announce voluntary withdrawal of oral infant medicines. 2007. http://www.chpa-info.org/10_11_07_OralInfantMedicines.aspx. Accessed May 26, 2009.

Food and Drug Administration. Public Health Advisory: Nonprescription cough and cold medicine use in children: FDA recommends that over-the-counter (OTC) cough and cold products not be used for infants and children under 2 years of age. 2007. http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm. Accessed May 26, 2009.

Food and Drug Administration. Nonprescription drug advisory committee meeting: cold, cough, allergy, bronchodilator, antiasthmatic drug products for over-the-counter human use. 2007. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4323b1-02-FDA.pdf . Accessed May 26, 2009.

American Academy of Pediatrics. Committee on Drugs. Use of codeine- and dextromethorphan-containing cough remedies in children. Pediatrics. 1997 ;99:918-920.

Schroeder K. , Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev. 2004;(4):CD001831. doi: 10.1002/14651858.CD001831.

10.

Irwin RS , Baumann MH , Bolser DC , et al. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006; 129(1 suppl):1S-23S.

11.

Henry J. Kaiser Family Foundation. Children’s OTC Cold Medicines: The Public, and Parents, Weigh in. Menlo Park, CA: Henry J. Kaiser Family Foundation; 2007.

12.

Food and Drug Administration. Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee: Meeting Announcement. June 29-30, 2009. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm . Accessed August 23, 2009.