Cold Medication Can Harm Young Children
Manufacturers of 14 popular cold and cough medications labeled for infants agreed to voluntarily withdraw the products from stores Oct. 11 as the Food and Drug Administration considers tougher regulations on the drugs.
The FDA will hold hearings this month on the safety of such products in light of concerns that they can be ineffective and cause serious – even fatal – complications if used improperly. The agency’s actions could range from stiffer warning labels and restrictions on packaging to a ban on over-the-counter cold medications for infants and toddlers.
Pediatricians and family practitioners at Children's Hospital Colorado do not recommend non-prescription cold and cough medications for children under age 2, and they echo regulators’ concerns that the drugs can do more harm than good.
“The FDA’s proposal to label cold medications with the warning ‘do not use in children under two years’ is consistent with what the Emergency Department providers at Children’s already routinely recommend,” said Marion R. Sills, MD, an attending physician in Emergency Medicine. “Because of the lack of safety evidence for use of these medications in infants and young children, the Emergency Department providers recommend the natural, safe and more effective methods for treating the symptoms associated with a cold.”
Safer methods include use of nasal saline drops, a nasal suction bulb and a water-containing cool-mist humidifier, Sills said.
Cold Care Tips
Children's Hospital Colorado’s aftercare instructions for colds and upper respiratory infections provide the following advice:
Common mistakes in treating colds
Nothing can make a cold last a shorter time. Over-the-counter cough and cold medications are not recommended, especially in children aged 2 years and younger. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. Some of the ingredients in these medications can lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.
Use acetaminophen or ibuprofen for a cold only if your child also has a fever, sore throat, or muscle aches, and avoid preparations that combine acetaminophen or ibuprofen with other active ingredients. Children under 18 years of age should not take aspirin or products containing salicylate because of the risk of Reye's syndrome unless recommended by a health care provider.
How are colds treated?
Because your baby has such small nasal air passages, congestion and mucus can cause trouble breathing. Most babies do not eat well when they are having trouble breathing. Use a small bulb and saline drops to help clear the air passages. Put 1 drop of warm water or saline into each nostril (one nostril at a time). Gently remove the mucus with the bulb about a minute later. Your health care provider can show you how this is done.
Over-the-counter cough and cold medicine can be harmful to children aged 2 years and younger, especially if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. Some of the ingredients in these medications can lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.
Antibiotics can kill bacteria, but not viruses. If your child has a viral illness such as a upper respiratory infection, an antibiotic will not help. If your child has an ear infection caused by bacteria, your health care provider may prescribe an antibiotic to treat it.
Other resources
Read more about infant cold medication safety from the FDA.
No healthcare situation is the same for all children, so parents and guardians should consult with their pediatrician or family practitioner to determine the best course of action for their child.
