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Adverse Reactions to Cough and Cold Meds Sent 1500 Babies to the Emergency Room in 2004, 2005

Worst Pills, Best Pills Newsletter article March, 2007

The Centers for Disease Control and Prevention (CDC) found that children under age 2 are at risk for illness or even death if they are given prescription or over-the-counter cough and cold medicine.

More than 1,500 children under two were treated in emergency rooms across the United States for overdoses and other adverse reactions associated with the use of cough and cold products in 2004 and 2005, according to a new CDC report that was published January 12 in the agency’s weekly...

The Centers for Disease Control and Prevention (CDC) found that children under age 2 are at risk for illness or even death if they are given prescription or over-the-counter cough and cold medicine.

More than 1,500 children under two were treated in emergency rooms across the United States for overdoses and other adverse reactions associated with the use of cough and cold products in 2004 and 2005, according to a new CDC report that was published January 12 in the agency’s weekly newsletter, Morbidity Mortality Weekly Report. The CDC report is available online here

In the report, the CDC made the following recommendations about administering cough and cold medications to children under 2 years of age:

Caregivers and clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged [less than] 2 years. Caregivers should only administer cough and cold medications to children in this age group when following the exact advice of a clinician. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient. Caregivers should always inform their health-care providers of all medications they are administering to a child.

In response to this report, the CDC and the National Association of Medical Examiners (NAME) investigated and identified three deaths in infants under six months of age. Coroners or medical examiners determined that the cause of death in the three infants was ingestion of cough and cold preparations.

The three infants who died ranged in age from 1 to 6 months. They all had high levels of the nasal decongestant pseudoephedrine (SUDAFED) in their blood. (We list pseudoephedrine as a Do Not Use drug for children and adults because it can raise heart rate and blood pressure.)  

Two of the infants received a single pseudoephedrine-containing drug, one prescription and one over-the-counter. The third infant had been given both a prescription and an over-the-counter cough and cold combination drug – each containing pseudoephedrine – at the same time.

Both of the infants who had been given a prescription had ingested a drug containing the antihistamine carbinoxamine.

There were also detectable blood levels of the cough suppressant dextromethorphan and acetaminophen (TYLENOL), the popular pain and fever reducing drug, in the two infants who received over-the-counter medication.

The CDC made its estimate of emergency room visits with a national tracking system called the National Electronic Injury Surveillance System – Cooperative Adverse Drug Event Surveillance (NEISS-CADES). This system was developed by the CDC, the Food and Drug Administration (FDA) and the Consumer Product Safety Commission to estimate the number of patients who visit emergency rooms annually because of adverse drug reactions.

Experts: Cough and cold medicines could put kids at risk
These findings should not come as a surprise – there have been multiple official statements regarding cough and cold management for children during the past decade.

In 1997, the American Academy of Pediatrics issued a policy statement advising that parents should be told that efficacy of the cough suppressants codeine and dextromethorphan in young children was unproven, and that there is a potential for adverse drug reactions.

In 2004, a systematic review done by the highly regarded Cochrane Collaboration, an international organization that reviews healthcare interventions, examined controlled clinical trials of over-the-counter cough and cold products. It found them no more effective than a placebo in reducing acute cough and other symptoms of upper respiratory tract infection (such as a cold).  

Two years later, the American College of Chest Physicians advised health professionals to stop recommending cough suppressants and other over-the-counter cough medications for young children because of associated adverse effects and the possibility of death.

Small children require different doses of medications  
No FDA-approved over-the-counter products have dosing recommendations for children less than 2 years old. Consumers are advised to consult their doctor for this age group.

Clinicians and health professionals commonly extrapolate a dose based on the patient’s age or weight for children younger than 2. Such an extrapolation is based on assumption – which may not be true – that the effects of drugs are similar in adults and children. Children are not little adults, meaning that they may handle drugs in a different way.

What You Can Do
The common cold is a mild, self-limiting condition that will resolve in about seven days whether it is treated or not. Colds are caused by a virus and antibiotics do not work against viruses; antibiotics should therefore not be used to treat colds.  

Prescription and over-the-counter cough and cold medications should not be used in children younger than 2 years of age.