Data do not support use of OTC decongestants in children

All drugs containing pseudoephe drine, the most commonly used over-the-counter (OTC) decongestant, are now stocked behind pharmacy counters and may be purchased only in limited quantities after consumers show identification and sign a logbook.

Dr. Paul

This change resulted from the Combat Methamphetamine Act, which was incorporated into the USA Patriot Improvement and Reauthorization Act of 2005, because pseudoephedrine is a key ingredient in making methamphetamine, a highly addictive and illegal stimulant.

Since the efficacy of other OTC cough and cold medications has been questioned, the change in the distribution of pseudoephedrine makes it timely to review the evidence regarding oral and topical nasal decongestants.

Oral and topical nasal decongestants are sympathomimetic agents that purportedly decrease nasal congestion by causing vasoconstriction. The reduced blood flow to the nasal mucosa and sinuses improves edema and increases the patency of the nasal passages. Currently available oral drugs include pseudoephedrine and phenylephrine; topical agents include oxymetazoline and phenylephrine.

Although some of these medications have been available for over 50 years, only five placebo-controlled studies of single agent oral or topical decongestants for the treatment of the common cold met the Cochrane Database of Systematic Review criteria for inclusion in its 2004 topic review ( Cochrane Database Syst Rev.2004 ;(3):CD001953 ).OpenUrlPubMed All of these studies were performed with adult participants. Therefore, findings must be extrapolated to children.

Pediatric studies have shown that topical phenylephrine did not relieve nasal congestion.

There also have been multi-ingredient, placebo-controlled studies not included in the Cochrane review, some of which have been conducted with children as will be discussed here.

The best studied oral agent in adults, both as a single and combination ingredient, is pseudoephedrine. It is most commonly taken to relieve congestion and rhinorrhea associated with upper respiratory infections (URIs). The majority of the evidence from adult studies included in the Cochrane review as well as those conducted since its publication and those with multiple ingredients do support a modest reduction of signs and symptoms associated with URIs reported both subjectively and objectively, with single doses of the drug. Notably, however, there is limited evidence supporting multiple doses over the course of an illness as well as an absence of supportive pediatric data.

The adult studies also report common adverse effects, including hypertension, tachycardia and sleeplessness.

Although oral phenylephrine shares some pharmacologic properties with pseudoephedrine, there is scant published evidence supporting its use for URIs. This is an important fact since some OTC preparations have substituted phenylephrine for pseudoephedrine in response to the new legislation, despite the poor oral bioavailability of phenylephrine. In fact, a recent review of the evidence for phenylephrine questioned the Food and Drug Administration approval process, stating that phenylephrine “is unlikely to provide relief of nasal congestion” ( Hendeles L, et al. J Allergy Clin Immunol.2006 ;118:279 -280OpenUrlCrossRefPubMed ).

For topical agents, again there are limited data describing the effects of phenylephrine, but supportive data demonstrate short-term beneficial effects of oxymetazoline in adult patients. Patients using this product, however, must be cautioned about chronic use given the well-described risk of rhinitis medicamentosa, a condition of rebound nasal congestion brought on by overuse of intranasal vasoconstrictive medications.

The few pediatric studies that have been conducted have failed to document beneficial effects of any of the compounds studied. Two studies evaluated oral antihistamine-decongestant combinations and found them no better than saline placebo ( Hutton N, et al. J Pediatr.1991 ;118:125 -130OpenUrlCrossRefPubMed ; Clemens C, et al. J Pediatr.1997 ;130:463 -466OpenUrlCrossRefPubMed ). Two others found no beneficial effects of topical phenylephrine ( Bollag U, et al. Helv Paediat Acta.1984 ;39:341 -345OpenUrlPubMed ; Turner RB, et al. Pediatr Infect Dis J.1996 ;15:621 -624OpenUrlCrossRefPubMed ). Notably, none of these pediatric investigations studied drugs containing pseudoephedrine.

In summary, there are little published data to support the use of OTC decongestants for URIs in children and none supporting the use of phenyl ephrine for children. Therefore, those providing health care to children with URIs must balance the modest positive effects shown with some of these drugs for adults with the limited pediatric data and potential for adverse effects.

Dr. Paul is a member of the AAP Section on Clinical Pharmacology and Therapeutics executive committee.