FDA to parents: Avoid cold meds in babies

The FDA warns that over-the-counter cold and cough medicines can lead to serious and potentially deadly side effects in kids younger than 2.

FDA to parents: Avoid cold meds in babies click to enlarge Dr. Mike Steiner offers his advice on caring for babies and small children with cold or flu.

Fever. Cough. Runny nose. Congestion. Fussiness. Cold symptoms in a baby or young child can cause great distress to parents and caregivers and misery in the household as everyone’s lives and sleep are disrupted. Indeed, the common cold is among the primary causes for visits to the pediatrician’s office.

As sleep deprivation sets in, it can be tempting to grab a bottle of children’s cold medicine to help the little one (and other members of the household) sleep through the night—but a recent warning issued by the U.S. Food and Drug Administration advises that over-the-counter medications should not be given to infants or children younger than 2.

“This issue has been getting increasing attention over the past five years as we have realized that cough and cold medication generally do not relieve cough and cold symptoms for young children, and there are significant risks, including deaths from overdose, that have occurred,” says Michael Steiner, MD, MPH, UNC Children's chief of general pediatrics.

A 2007 advisory from the FDA regarding the safety of over-the-counter infant cough and cold medicines led manufacturers to voluntarily pull such products from the market in 2008.  Drug makers further re-labeled medications meant for older children, adding a warning that states, “Do not use in children under 4 years of age.”

 Study of the matter in the years since these changes were enacted, however, has led to renewed concern that parents are giving products designed for older children to their infants and young children, mistakenly believing they can safely adjusting the dosage to account for the baby or child’s smaller size.

“While over-the-counter medications can sometimes help relieve symptoms in older children, they won’t change the course of the cold or make it go away,” says Steiner. “Patience will get your child back to their old selves, and never hesitate to call your pediatrician for a little extra support and advice if your worries persist.”

What can a worried parent do?

“Some accumulated data suggest using old-fashioned remedies, such as honey for children over 1 year of age and mentholated rubs for older children, can be effective,” advises Steiner. “But for the youngest children, acetaminophen for discomfort and saline nasal spray or suction will be enough to help them through cough and cold season.”

Parents and caregivers still need to watch for signs that something more serious than a cold is involved. These signs include:

  • Fever in an infant 2 months or younger
  • Fever of 102 or higher in any child
  • Signs of labored breathing—nostrils widening with each breath, wheezing, fast breathing, or the ribs showing with each breath
  • Blue lips
  • Not eating or drinking with signs of dehydration
  • Ear pain
  • A cough that lasts more than three weeks
  • A child whose illness is getting worse after 3-4 days instead of slowly getting better.

“Remember also, that during colds, children will often regress on important milestones, like sleeping through the night by themselves,” says Steiner. “But call a pediatrician should any of the more serious symptoms appear.”


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