2007-01-24 00:00:00

Cough and Cold Medications May Cause Infant Death

January 16, 2007 ? The US Food and Drug Administration (FDA) has warned healthcare professionals regarding the need for caution when administering cough and cold medications to infants younger than 2 years. Clinicians should also ask caregivers about their use of over-the-counter (OTC) combination medications to avoid the risk for overdose from component duplication.

The warning was based on 3 infant deaths for which cough/cold medications were determined by medical examiners to be the underlying cause, according to an alert sent Friday from MedWatch, the FDA’s safety information and adverse event reporting program.

According to an article published by the US Centers for Disease Control and Prevention in last week’s Morbidity and Mortality Weekly Report, the 3 infants ranged in age from 1 to 6 months; all were found dead in their homes. On autopsy, 2 of the infants (patients 1 and 2) had evidence of respiratory infection.

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. Two of the infants (patients 1 and 3) had received either an OTC or a prescription product, and patient 2 had received both.

Further examination revealed that patients 2 and 3 had detectable blood levels of dextromethorphan and acetaminophen. Although no detectable postmortem levels were found, patients 1 and 2 had been administered prescription medications containing carbinoxamine.

The CDC notes that although OTC sales of pseudoephedrine-containing products have been banned, some pediatric cough and cold medications containing the drug may still be sold behind the counter.

As an alternative to cough and cold medication in infants, use of a rubber suction bulb to clear congestion should be considered; secretions can be softened with saline nose drops or a cool-mist humidifier.

According to the CDC, systematic reviews of controlled trials of OTC cough and cold medications have concluded they are not more effective than placebo for reducing acute cough and other symptoms of upper respiratory tract infection in children younger than 2 years. Moreover, the American College of Chest Physicians released clinical practice guidelines in 2006 advising healthcare professionals to refrain from recommending cough suppressants and other OTC cough medications for young children because of associated morbidity and mortality.

Currently, there are no FDA-approved dosing recommendations for administering OTC cough and cold medications to infants younger than 2 years. OTC labeling advises caregivers to “consult a doctor” for children in this age group; clinicians often extrapolate a dose from guidelines for older children and adults based on the child’s age or weight, assuming that the disease and drug effects are similar.

Healthcare professionals are advised to educate caregivers regarding the importance of administering cough and cold medications only as directed and the risk for potentially fatal overdose associated with ingredient duplication if additional products are given.

Adverse events potentially related to use of cough/cold products in children younger than 2 years should be reported to the FDA’s MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.?

Filed under: — @ 2007-01-24 00:00:00