Cold and cough medications used for temporary symptomatic relief have been associated with significant adverse effects in children less than 2 years of age. The US Food and Drug Administration (FDA) Public Health Advisory, in Jan 2008, had recommended against the use of nonprescription cold and cough drugs in children under 2 years. The efficacy of these medications versus the potential side effects seen in these children was a point of controversy in several studies. Now, a new study, published in the August issue of Paediatrics , has reported ten unexpected infant deaths associated with the use of over-the-counter cold medications, leading to further concern regarding their injudicious use.
US researchers, Mary E Rimsza of the University of Arizona College of Medicine, Tucson, Arizona and Susan Newberry, Arizona Child Fatality Review Program, Arizona Department of Health Services, Phoenix, Arizona reviewed the data of all unexpected infant deaths (aged 17 days to 10 months) that occurred in the State of Arizona during 2006. Further analysis of medical records, autopsies and postmortem toxicological studies were conducted. Evidence of recent administration of pseudoephedrine, antihistamine, dextromethorphan, and/or other cold-medication ingredients was detected in the postmortem toxicology analysis of these infants. Of the ten infants, the medication had been prescribed by a clinician for only one infant, and the rest were administered the drugs without consulting a doctor.
Similar adverse effects and mortality due to drugs like antihistaminics, nasal decongestants, and cough expectorants and suppressants have been reported by the Centers for Disease Control and Prevention (CDC) in a 2007 report. Adverse effects were reported in 1,519 children less than 2 years, from 2004 to 2005, and deaths of 3 infants aged younger than 6 months were attributed to these medications. Other studies have also demonstrated comparable results.
In another study published in the recent issue of Pediatrics, Vernacchio, et al. reported that approximately one among every ten children in the US use cough and cold medicine in a given week. The researchers reviewed the use of such medications among 4,267 US children less than 18 years of age, enrolled in the Slone Survey during the 1999-2006 period. The researchers concluded that though the prevalence rate of younger children using cough and cold medications is significantly high, there is a lack of sufficient data to support the use of such medications in this age group.
Currently, there are no FDA-approved dosing recommendations for over-the-counter cough and cold medications for children younger than two years of age. Though suggested dosing for some cough and cold medications are given in parenting and prescribing guides, physicians are usually calculating the dosages for this age group from the dosing guidelines for older children and adults, and also based on their weight or age.
In view of the high prevalence in the use of cold and cough drugs, lack of proven efficacy, potential serious adverse effects and absence of clear dosing schedules for children below 2 yrs of age, extreme caution needs to be exercised in its prescription to this age group. Caregivers also need to be educated regarding use of over–the-counter medications and the need to consult a clinician before their use. Meanwhile, use of saline nasal drops, suction bulbs to clear mucus in babies and cool mist humidifiers are more effective measures to provide symptomatic relief without any potential harmful effects.
References
1. Rimsza ME, Newberry S. Unexpected Infant Deaths Associated With Use of Cough and Cold Medications. Pediatrics. 2008 Aug;122(2):e318-22.
2. Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications–two states, 2005. MMWR Morb Mortal Wkly Rep. 2007 Jan 12;56(1):1-4.
3. Vernacchio L, Kelly JP, Kaufman DW, Mitchell AA. Cough and cold medication use by US children, 1999-2006: results from the slone survey. Pediatrics. 2008 Aug;122(2):e323-9.
