Issue: February 2008
February 01, 2008
2 min read

OTC cold medications no longer recommended for children younger than 2

OTC cough, cold products not proven safe or effective in this age group.

Issue: February 2008
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Due to the potential for serious adverse events in children aged younger than 2 years, over-the-counter cough and cold products should no longer be given to children in this age group, according to a recent Public Health Advisory issued by the FDA.

This advisory is based upon discussion and review of data at the Oct. 18-19, 2007 joint meeting of the Nonprescription Drugs and Pediatric Advisory Committees.

Additionally, a study by the CDC recently concluded that an estimated 7,000 children aged 11 and younger are treated in hospitals for adverse events related to cough and cold medication.

“The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children aged younger than 2 years. These products, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children aged younger than 2 years,” Charles Ganley, MD, director of the FDA’s Office of Nonprescription Products, said in a press release.

“The FDA’s recent recommendation against the use of OTC cough and cold products in children aged younger than 2 years is an important step in the right direction in the care of infants with the common cold,” Edward A. Bell, PharmD, professor and pharmacotherapy specialist in pediatrics at Drake University College of Pharmacy, told Infectious Diseases in Children.

Bell writes Infectious Diseases in Children’s regular Pharmacology Consult column.

“These products have been used for years without evidence-based scientific data demonstrating their efficacy. Yet, case reports of significant adverse effects, including death, have been published. Although inappropriate product use by caregivers may have been a contributory factor in many of these cases, inherent difficulties also exist in the use of these products. These include dose determination, accurate measurement of small liquid doses, use of multi-ingredient products and belief by caregivers that OTC products have minimal risk, given their availability,” Bell said.

Because review of OTC cough and cold product use in the 2 years to 11 years age group is still ongoing, the FDA recommends parents and caregivers of children who choose to continue using OTC cough and cold products to:

  • Follow the label’s dosing directions for all OTC medications.
  • Know that these medications will not cure or shorten the duration of the common cold.
  • Check the drug facts label to learn what active ingredients are in the products because they may contain multiple active ingredients.
  • Only use measuring spoons or cups that come with the medicine or those made especially for measuring medication.

“Pediatric clinicians can recommend nasal saline administration, bulb suctioning and air humidification as alternatives. These therapies are likely to be much safer,” Bell said. “Acetaminophen and ibuprofen for children aged 6 months and older can be given for discomfort. Keep in mind, however, that caregivers often do not dose these drugs correctly either, so recommend a specific weight-based dose and product dosage form to the infant’s caregiver. Educate caregivers of infants on the common cold and about how drugs are not always as helpful as we would like them to be.”

FDA officials recommend that parents and caregivers contact their physician, pharmacist or a health care professional with any questions on how to treat a child with a cough or cold. – by Jennifer Southall

For more information:
  • For more information on OTC cough and cold medication use in children, visit