By Eric Ball, M.D.
The contents of this web site are provided as an informational tool. This is not intended to replace medical advice or care administered by a healthcare professional. Common sense should always be used when referencing this site. If, at any time, you feel your child is experiencing a medical emergency, call 911 immediately.
It is the most basic of parental instincts to care for a sick child. In this day and age, that care has come to include over-the-counter cold medications that have been aggressively marketed to parents. Unfortunately we now know that these pediatric versions of adult medication may actually do more harm than good.
On October 19, 2007, the Food and Drug Administration’s Nonprescription Drugs Advisory Committee recommended that over-the-counter cold and cough medicines not be used in children who are 2 to 5 years old. This announcement came on the heels of a major recall of cough and cold medications marketed to children under 2 after reports of potentially dangerous side effects surfaced.
Many parents have been confused by this recent recall and FDA advisory. There are three main reasons why we no longer recommend these medications for children under six years old.
COLD AND COUGH MEDCATIONS DO NOT WORK IN CHILDREN. There have been few studies that have actually looked at the efficacy of cold and cough medications in alleviating cold symptoms in children. Of the studies preformed, EVERY study done since 1985 has shown no benefit to any of these medications versus a placebo. In other words, each study showed that a sugar pill had the same effects as did the cold medications. Cough medications did not stop coughs, decongestants did not make children less congested, and expectorants did not make mucous any more manageable. Even if the medications did work, they would only treat symptoms of a cold; they do not cure or shorten the duration of the illness. Children get better with time.
SAFE PEDIATRIC DOSAGES OF THESE MEDICATIONS HAVE NEVER BEEN ESTABLISHED. When the original dosing studies for these over-the-counter cough and cold medications were performed, safe dosages were established only for adults. The FDA licensed the medications for children in 1976 without any studies establishing safe doses for children. Pediatric dosing was extrapolated from adult dosing using a crude formula: half of the adult dose for children between 6 and 11 years of age and a quarter of the adult dose for children between 2 and 5 years of age. For children under 2 years of age, parents were instructed to ‘contact your doctor.’ These extrapolated doses are imprecise and potentially dangerous; it puts children at much higher risk for adverse effects and accidental overdose.
COLD AND COUGH MEDICATIONS HAVE MANY DANGEROUS SIDE EFFECTS IN CHILDREN. Since 2000, poison-control centers have reported more than 750,000 calls related to effects from over-the-counter cold medications in children. The FDA has reported 123 deaths related to these medications as well. Because appropriate dosing has not been established, side effects tend to be more pronounced in children. Cough suppressants, which are derived from narcotic-type medications, often cause drowsiness, confusion, and other neurologic effects. Decongestants are related to amphetamine-type medications and cause agitation, insomnia, restlessness, and high blood pressure. Antihistamines, which are often marketed as ‘night-time’ medications, cause drowsiness in some children and agitation in others. Expectorants can cause gastrointestinal effects, such as nausea, vomiting, and diarrhea.
There is no ‘cure’ for the common cold, but there are some things you can do while the virus runs its course. Make sure your child drinks plenty of fluids. This will serve to thin mucous and keep him well hydrated. Saline drops or sprays can offer temporary relief of a stuffy nose. A bulb syringe can be used for children too young to blow their noses. A humidifier is often helpful for decreasing congestion at night. Acetaminophen or ibuprofen (for children over six months old) are safe and effective in relieving pain or fever associated with a cold.
With these tips parents will find safe and effective ways to soothe their children’s symptoms during the forthcoming cold and flu season. Southern Orange County Pediatrics wishes you a happy and healthy New Year!
Sharstein JM et al. Over the Counter but No Longer under the Radar—Pediatric Cough and Cold Medications. New England Journal of Medicine, December 6, 2007.
American Academy of Pediatrics Committee on Drugs. Use of Codeine- and Dextromethorphan-Containing Cough Remedies in Children. Pediatrics, June 6, 1997.
AAP website. www.aap.org
FDA website. www.fda.gov