Fewer Child Poisonings Linked to Cough and Cold Medicine

Emergency room visits for cough and cold medication (CCM) adverse events among infants and toddlers declined nation-wide following the 2007 withdrawal of over-the-counter (OTC) CCMs from the market and a 2008 labeling revision warning against OTC CCM use by children under four years old. According to a study from the American Academy of Pediatrics, adverse drug events (ADEs) related to CCMs dropped by over 40 percent for children under two years old and by over 30 percent for children between the ages of two and three; the majority of CCM ADEs after these changes were caused by unsupervised ingestions.

CCM Interventions

Manufacturers voluntarily withdrew all OTC infant CCMs from the United States market in October 2007 after CCMs were linked to significant numbers of infant emergency department visits and rare cases of infant death. Studies had shown CCMs are no more effective than placebos in young children. The FDA formally supported the withdrawal. One year later, in October 2008, OTC CCM manufacturers announced, with FDA support, that OTC CCM labels would be revised to state that the medications should not be used in children under four years old. These changes attracted media attention and are the subject of ongoing educational efforts by the FDA, professional organizations, and trade groups.

Study Findings

After each intervention, calls to poison centers and emergency department visits reporting CCM ADEs decreased among young children and infants. For children over four years of age, the proportion of ADE emergency visits attributed to CCMs did not significantly change. The market withdrawal and labeling revision were directed primarily at preventing ADEs resulting from the intentional administration of CCMs to children by caregivers. Although these visits have not been eliminated, they have declined as a proportion of visits and also caused a corresponding decline in the overall number of emergency visits. Despite the interventions, many parents reported giving a child under three years old a CCM the last time the child had symptoms of an upper respiratory tract infection. The study recommends additional educational efforts regarding the risks of pediatric CCM use, directed at parents and medical providers, to further decrease the CCM ADEs. Because unsupervised ingestions were not affected by these interventions, further changes are necessary. The study recommends improved packaging designed to limit access to medications for young children, and safer medication handling and storage practices.

CCM Alternatives

The FDA recommends some common alternative treatments to help infants and young children suffering from cough and cold symptoms. They include:

  • A cool mist humidifier to help nasal passages shrink and allow easier breathing;
  • Saline nose drops or spray to keep nasal passages moist and help avoid stuffiness;
  • Nasal suctioning with a bulb syringe either with or without saline nose drops, especially for infants less than a year old;
  • Acetaminophen or ibuprofen, if the product’s instructions for use label is followed carefully, can reduce fever, aches and pains; and
  • Drinking plenty of liquids will help the child stay well hydrated.