Meds in Kids

By Adriane Fugh-Berman, M.D.

In October, an FDA advisory committee concluded that cough and cold remedies should not be given to children under six years old, and that there was no evidence that they were effective in children under 12. A pediatrician group led by Joshua Sharfstein, Baltimore’s Health Commissioner, brought this issue to the FDA’s attention.

Hurray for Commissioner Sharfstein and his colleagues for taking on this issue. Until recently, there were dozens of cough and cold medications available over-the-counter to treat children, and they were widely used. Some products featured pictures of smiling babies, or the words “doctor-recommended.” In fact, cough and cold medications should not be given to infants at all, but it’s understandable that parents might assume, incorrectly, that the products that are readily available at the drugstore have been tested and found to be safe and effective.

Many over-the-counter products have never been tested in children (nor have many prescription drugs). One problem ingredient in cough and cold remedies is pseudoephedrine, a decongestant that can cause increased blood pressure and abnormal heart rhythms in children and adults – it can cause deaths in infants. Dextromethorphan (often abbreviated as “DM”) can cause neurological problems, including hallucinations and abnormal movements in infants.

Not only is dextromethorphan dangerous, it doesn’t seem to be effective in children. One study found that neither dextromethorphan nor diphenhydramine (Benadryl and other brands) was better than a placebo (a sugar syrup) for cough or sleep quality in children.¹

The concentrated sugar syrup used as a placebo in this study may have been therapeutic on its own.²  Sweet syrups soothe the throat. Honey, a common ingredient in home remedies for colds, appears to be an effective cough treatment. A recent study in children and adolescents between the ages of 2--18 compared dextromethorphan to honey and to no treatment for coughs associated with upper respiratory infections. Honey was better than dextromethorphan, which was just as ineffective as no treatment at all.³  (It bears noting that funding for this study came from the National Honey Board.) Honey, by the way, should never be used in babies under one year of age; differences in immune function puts babies at risk of botulism from spores that can be found in honey.

In response to the petition submitted to the FDA by Commissioner Sharfstein and his colleagues, drug companies voluntarily pulled 14 infant cough and cold medications from the market before the FDA committee had even met.⁴  (This may have been an effort to avoid having the remedies banned for children altogether.)

So what’s a parent with a sick baby to do? A baby who is lethargic, not eating, not urinating, or is having trouble breathing needs to be evaluated by a health care provider; fever in a baby less than three months old should be evaluated as well. But for cough, sniffles, congestion, runny nose, or fever, simple home remedies are the best solution.

Humidifying the air may be the most effective measures, as dry air can aggravate a cough or sore throat. Cold mist humidifiers are more popular than steam humidifiers because the latter can burn a child, but a major drawback of cold mist humidifiers is that they must be cleaned every day or two with a diluted bleach solution to prevent the growth of mold, which can then be spewed into the air. Steam humidifiers are fine for infants because they can’t crawl yet; just keep babies at least three feet away from the steam. Some doctors recommend using the bathroom as a steam room: take a congested or coughing baby into the shower with you, dry off, and then sit with the baby in the bathroom for another 10 minutes or so to take advantage of the residual steam.

It’s also important to make sure that a baby or child is drinking plenty of fluids, which will help to thin mucus and make it easier to expel. A baby can’t blow his or her nose, so inserting a few drops of (unmedicated) saline nose drops into one nostril at a time and gently suctioning the nostril with an infant bulb syringe can help. You can make a saline solution for nose drops at home by adding half a teaspoon of salt to a cup of boiled and cooled water, and stirring until it is dissolved. A small wedge placed under the mattress to tilt the baby so that his or her head is slightly higher than his or her feet may also help mucus to drain. Never use pillows to prop a baby up as this can increase the risk of suffocation.

For fever, a dose of acetaminophen (Tylenol and other brands) or ibuprofen (Advil, Motrin, and other brands) along with a lukewarm sponge bath can rapidly bring down a fever. To give a sponge bath, put the baby in a baby bath with lukewarm water, and sponge water over the baby’s head, shoulders, and chest for about 10 minutes.

There are still plenty of cough and cold remedies on drugstore shelves; it’s best to leave them there and use the simple home remedies described above instead.

Adriane Fugh-Berman, M.D., is an associate professor in the Georgetown University School of Medicine, Dept. of Physiology, and a former chairof the NWHN.

REFERENCES

1. Paul IM, Yoder KE, Crowell KR, et al. “Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents,” Pediatrics 2004; 114(1):e85-e90.

2. Walburn A. “Effect of dextromethorphan, diphenhydramine,and placebo on nocturnal cough and sleep quality for coughing children and their parents (letter),” Pediatrics 2004; 114 (5): 1370.

3. Paul IM, Beiler J, McMonagle A et al., “Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents,” Arch Pediatr Adolesc Med. 2007; 161(12):1140-6.

4. Emery C. “FDA panel urges ban,” Baltimore Sun, October 20, 2007.