All 3 infants had what appeared to be high levels of pseudoephedrine in postmortem blood samples (range, 4743 - 7100 ng/mL). According to the CDC, these levels are approximately 9 to 14 times the levels resulting from administration of recommended doses to children aged 2 to 12 years.The findings underpin the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children aged
Currently, there are no FDA-approved dosing recommendations for administering OTC cough and cold medications to infants
The January 12th issue of the US CDC’s Morbidity and Mortality Weekly Report stated that during 2004 and 2005, approximately 1500 children less than 2 years old were treated in US emergency departments for adverse events associated with cough and cold medications. The US FDA has similarly warned healthcare professionals about the need for caution when administering cough and cold medications to infants younger than 2 years. Clinicians should also ask caregivers about their OTC combination medications to avoid the risk for overdose from component duplication
In an editorial note, the CDC says controlled trials indicate that cough and cold medications are no more effective than placebo in children younger than 2 years of age. Furthermore, the American College of Chest Physicians in 2006 released clinical practice guidelines for management of cough, advising clinicians to refrain from recommending cough suppressants.
Alternative, safer and and probably more effective treatments for young patients' symptoms include softening nasal secretions with saline nose drops or a cool-mist humidifier, then clearing nasal congestion with a rubber suction bulb.
Adapted from: Morbidy & Mortality Wkly Rep CDC Surveill Summ 2007;56:1-4.
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