The recent FDA voluntary withdrawal of cough and cold OTCs for infants has created a void that pharmacists should fill with patient counseling.
A debate has been raging over what over-the-counter (OTC) cough and cold products should be used in pediatrics. This debate was prompted by a January 2007 study published in Morbidity and Mortality Weekly Report which noted that 1,519 children were treated in U.S. emergency departments for adverse events related to cough and cold drugs in 2004-2005. The Centers for Disease Control & Prevention and the National Association of Medical Examiners found that three infants under six months of age died from causes attributed to cough and cold drugs in 2005. The underlying causes of deaths were listed as pseudoephedrine intoxication, pseudoephedrine and dextromethorphan intoxication, and drug poisoning.
In response to the CDC's investigation, members of the Food & Drug Administration's Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee voted to reject use of these drugs in children under the age of six. As most pharmacists are aware, no FDA-approved dosing recommendations for kids younger than two have ever existed for OTC cough and cold products. However, what R.Ph.s may not know is that safety and efficacy data for kids under 12 had been extrapolated from adult studies.
Ian Paul, M.D., M.Sc., associate professor of pediatrics and public health sciences and director of the pediatric clinical research office at Pennsylvania State University College of Medicine, commented, "There are some good data for decongestants, but extrapolation of adult data for children can be problematic due to side effects of the medication." In fact, Paul does not recommend any cough and cold meds for kids under 12. Instead, he suggests "Tylenol or Motrin for pain relief, saline nose drops, humidified air, and adequate hydration." Having led extensive research on the efficacy of cough suppressants in children, Paul reminded pharmacists, "Studies have found dextromethorphan to be no better than placebo." Additionally, he believes antihistamines show extremely weak evidence for treatment of cough and cold symptoms, although these drugs can be used in kids experiencing anaphylaxis and allergic rhinitis.
However, if parents feel they need to give their child something for cold symptoms, in his recently published and widely publicized Archives of Pediatrics & Adolescent Medicine study, Paul found an item often found in the kitchen pantry-buckwheat honey. He said honey "was superior to dextromethorphan in all outcomes" for suppressing cough in children, perhaps by coating and soothing the irritated throat.
Ultimately, when it comes to efficacy of OTC cough and cold products, more studies will be needed to determine safety and efficacy in tots, which could take two to three years. For now, William Wood, R.Ph., a pharmacist with Giant Eagle Pharmacy in Brentwood, Pa., noted, "Parents can feel helpless when their child is sick, but it?s important to avoid giving children unnecessary medication." Wood added that parents should contact their pediatrician if their kids present with high fever and any discoloration in their nasal discharge.
Until more data on cough and cold medication use in children become available, the FDA is being urged by patient advocacy groups to mandate standardizing dosing unit terminology to reduce confusion that may contribute to product dosing errors. Others are lobbying for prominent display of generic name and strength of all ingredients, warnings about the use of these drugs in children, and mandatory dosing devices included in product packaging.
KELLY KARPA is assistant professor, department of pharmacology, at Pennsylvania State University College of Medicine. MEGAN BARNES is obtaining her Pharm.D. degree from Duquesne University. AVANI PATEL is completing his Pharm.D. degree at University of Pittsburgh.