The Centers for Disease Control and Prevention hopes that media coverage will help spread awareness of its recommendation that parents consult a physician prior to administering OTC cough/cold drugs to infants under age two.

"Parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting a healthcare provider, and should follow the provider's instructions precisely," CDC states in the Jan. 12 Morbidity and Mortality Weekly Report.

Moreover, "clinicians should use caution when prescribing cough and cold medications to children aged <2 years," MMWR adds. The recommendations are being issued because of "the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children aged <2 years."

CDC pointed out that many drugs already are labeled to indicate that a physician should be consulted prior to dosing for infants. For example, Infants' Tylenol Plus Cold & Cough provides dosing directions for children ages 2-3, but says parents should "call a doctor" if the child is under two.

The center says it is important to "raise awareness about the potential serious harm of these drugs." Although the public health community is the audience for the MMWR, CDC expects that the message will be passed along to the general public via the media.

According to the MMWR article, there were 1,519 children under the age of two during 2004-2005 who were treated in emergency rooms for adverse events associated with cough/cold products.

The high number of adverse events led CDC to conduct an email survey, which identified three infants ages 1-6 months who died during 2005 due to use of cough/cold products.

All three infants had high levels of pseudoephedrine in their blood. However, two of the infants had been administered prescription drugs containing carbinoxamine, which was the focus of an FDA enforcement action in June. The agency at that time took action to stop companies from manufacturing carbinoxamine-containing drugs that had not been approved (¹ Also see "FDA Employs Carrot, Stick Under Unapproved Drug Enforcement Strategy" - Pink Sheet, 12 June, 2006., p. 3).

CDC has fewer concerns about pain relievers and fever reducers such as ibuprofen and acetaminophen, and is more focused on the safety of other ingredients that act as expectorants, decongestants, antihistamines and cough suppressants, according to Adam Cohen, M.D., one of the authors of the MMWR article.

CDC's concerns about the safety of cough/cold products for infants are mirrored somewhat by a recent article in AAP News, a monthly publication of the American Academy of Pediatrics. Author Ian Paul, M.D., asserts that "there are little published data to support the use of OTC decongestants for Upper Respiratory Infections in children and none supporting the use of phenylephrine for children."

"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 events," he adds. Paul is a member of AAP's Section on Clinical Pharmacology and Therapeutics executive committee. Paul points out most studies of oral or topical decongestants for the treatment of the common cold are performed in adults, requiring that findings be extrapolated to children.

Although the AAP has no official position on the matter, it is unlikely that any official position would differ in tone from Paul's article, according to Wayne Snodgrass, M.D., Ph.D., chairman of AAP's Committee on Drugs.

Snodgrass stated OTCs are "not useful" for treatment of children, in the sense that they do not change the outcome of the illness. While some symptomatic relief can be shown in adults, there is less evidence of such relief for young children, he said. He added that the benefit/risk ratio of the symptomatic relief provided is "really not in favor of" administering the drugs, particularly to young infants, because of the narrow margin of safety.

Snodgrass echoed CDC's comment about public awareness, saying that the media coverage of the MMWR article will bring attention to the issue.

FDA also expressed an interest in focusing on OTC use in infants. The agency stated in a recent Federal Register notice that it intends to address the lack of standardization in pediatric products, particularly for children under the age of two, in the near future (² Also see "FDA Proposes Liver, GI Risk Warnings For OTC Pain Relievers" - Pink Sheet, 1 January, 2007., p. 3).

- Bridget Behling

CDC Expects Media To Spread Message About Infant Use Of Cough/Cold OTCs

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