A Conversation with Dr. Dart: Cough and Cold Medications are Safe for Children; Just Give the Right Dose
Barbara Lock, MDApril 22, 2009
Following several high profile reports of death in children exposed to cough and cold medication, the Federal Drug Administration (FDA) issued a public health advisory warning that children under age 2 should not be given these preparations, and began a review of their safety in children age 2-11. Soon after, the British Commission on Human Medicines advised against the use of over the counter cough and cold medicine in children under age 6, and the Israel Health Ministry soon followed suit, restricting sales of cough and cold medications for children under age 6.
It didn't make any sense to me. Were children dying after their loving mother suctioned snot out of their nose and gave them the correct dose of cough or cold medicine? Was the risk of death in children from cough or cold medicine higher than the risk that someone would toss them out of the window in total-viral-syndrome-exasperation? I dutifully told the parents of congested and coughing children in my clinical practice of Emergency Medicine to avoid using cough and cold medicine unless prescribed by a doctor, and then stockpiled the stuff for my own kids in case it was taken off of the market. My pediatrician brother and sister-in-law were aghast (not the first time), when they saw me dosing the stuff for snotball number three, who was, at the time, only 1 1/2 years old.
To get a better idea of the true risks of cough and cold medicine in children, I contacted Richard C. Dart, MD, PhD, the Director of the Rocky Mountain Poison and Drug Center, which serves Colorado, Nevada, Montana and Hawaii. He is the lead author of a scientific study of deaths in children associated with over the counter cough and cold medications, published this month in the Annals of Emergency Medicine.
Medpie.com: I have never seen the death of a child from a cough and cold medicine in my clinical practice in emergency medicine. How common is it?
Dr. Dart: Pediatric deaths from cough and cold medicines are rare. After searching multiple sources spanning a period of at least 40 years, the cough and cold panel found only 103 deaths associated with an over the counter cough and cold product. Many of these deaths involved other causes as well. For example, an infant sleeping with an adult – a known risk factor for suffocation.
When the dose of the medicine that a child had received could be assessed (88 cases), the panel found that none of them involved a therapeutic dose. Since many millions of children were treated with these products over this period, your experience is accurate – the chance of any physician having treated a child who died from cough and cold medicine is vanishingly small.
There are two scenarios associated with a pediatric death and cough and cold medicine: 1) Accidental overdose, which could be from the child ingesting the medication themselves or a caregiver inadvertently giving multiple doses that resulted in a large overdose or 2) intentional overdosing by the caregiver in order to punish the child or heavily sedate them.
Medpie.com: I have always given my own children decongestants and antihistamines like pseudoephedrine and diphenhydramine when they have a cold. Have I been making a terrible mistake?
Dr. Dart: You have not been making a mistake as long as you use them at the appropriate dose on the product label. We have not found a pediatric death where it appeared that a true therapeutic dose was administered – they were all overdoses. However, some of them did involve parents or other caregivers who accidentally gave the overdose while treating the child. The margin of safety is wide, but a ten fold overdose (especially if repeated) will produce adverse effects and potentially could lead to death.
However, I should point out that some authorities have claimed that the cough and cold medications have been proven not to work in children. I believe this is a misleading over statement. An accurate summary of the medical literature indicates that we can’t tell whether these products work in children. This creates a problem for the FDA because millions of families use these medications, but the FDA has never required the manufactures prove that these medications are effective in children. This may seem surprising, but the cough and cold medications have been around a very long time. Like other medications, they were approved by a ‘grandfather’ clause. Many of us believe that our experiences with our own children indicate that they do work. However, it’s a valid criticism that there is no clear cut proof that these medications have a clinical effect in small children. It is my understanding that the manufacturers of the products are currently investigating the medications to demonstrate their efficacy in children. There is solid evidence that these medications work in adults.
Medpie.com: Why do you think that parents or caregivers give the wrong dose of medicine to children?
Dr. Dart: The review panel found some startling examples in the deaths they reviewed. In some cases, parents were found guilty of child abuse or manslaughter. Unfortunately, there’s a very small group of caregivers in the world who intentionally try to hurt the children under their care, and cough medicines is one way that they may try to do that.
There were some other cases where it appeared that the caregivers intended to treat cough and cold symptoms, but serious mistakes were made. These mistakes included administering doses that were much too large through an error in measurement as well as combining drugs that the parents didn’t realize contained the same ingredients.
Some rules to remember:
• Do NOT use cough and cold preparations intended for adults in children.
• Try to use the measuring cup provided with the product. If not available, use a clearly marked measuring device with markings that you understand.
• Never pour medicine directly into a child’s mouth.
• Check the label of medicine to make sure the same ingredient is not contained in other products you are giving your child.
• Follow the product label. You can’t administer a dangerous overdose if you follow the directions.
Medpie.com: For some reason, I imagine that parents or caregivers who may have given children a larger dose on purpose with the intention of making the child sleep may have lied to investigators about the dose given. Have I been reading too many crime novels?
Dr. Dart: There is an important distinction between giving a dose of cough and cold medicine to reduce a child’s distress from cough and cold symptoms and thereby allow sleep, and giving a dose that induces sedation or quiets the child. It takes a much larger dose to quiet a child than it does to simply facilitate sleep. The difference is an overdose versus a therapeutic dose. If caregivers follow the package label, they will always give an appropriate dose.
Medpie.com: What kind if technology is available to reinforce the correct timing and dosing of prescription and non prescription medications?
Dr. Dart: There are several potential solutions, but the timing of a dose is not really the issue. If the correct dose is given, even a double dose or an early dose will not make a child seriously ill. For example, there are pill containers available that can record the time that a dose was removed and “lock out” the user until it is appropriate to take another dose. However, these are expensive and overkill in my opinion.
It’s important to remember that a small overdose is not harmful to a child. For example, most poison centers in the United States do not refer a child into healthcare until the dose ingested is several times the normal therapeutic dose. Thus, if the normal dose was a teaspoon, we would not refer the patient in for medical care until they had been given several times that dose. There is a substantial margin of safety with these medications, but like any medication, that margin of safety can be overcome when someone gives repeated small overdoses or one massive overdose.
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