FDA to Decide if Cough & Cold Medicines are Safe for Children

Heidi L. Banko, PharmD/MBA Candidate 2008
Shenandoah University
Prepared during Consumer Health Information Corporation Clerkship
McLean, VA

Between 2004 and 2005, the Centers for Disease Control (CDC) reported that 1500 children under two years of age were taken to the Emergency Department because of overdoses and adverse effects of cold medicines. What’s more, some research shows that cough and cold medicines are not effective in young children.

The reports have come to the attention of the FDA. In response to these issues, the FDA has been reviewing the safety and efficacy of cough and cold products in children since last year. The FDA announced recently that the Nonprescription Drugs Advisory Committee will meet on October 18-19, 2007 to further review and discuss the safety and effectiveness of cough and cold drugs in children.

Parents want to help
No one likes getting a cold, but a child’s cold can be hard on the child as well as their parents. Children get 6-8 colds per year that typically last 3-14 days. Well-meaning parents that want to help their sick child will often give a cold or cough medicine to their child. They may mistakenly believe that over-the-counter (OTC) medicines are safe simply because they are available without a prescription. However, it has not been proven that these OTC products for cough and cold are safe or effective. Just because a drug is OTC and is approved by FDA does not mean that it will shorten the length of the cold.  Nor is it free of side effects.

Caution: If your child is under 2 years old
Children are more sensitive to medications than adults. OTC products can be harmful, especially in children under 2 years old. Nearly all drugs have the potential to cause harm, especially when too much is taken. Children can accidentally be given too much of an OTC medication. When reading the dosing information on the medicine, you may see “if under 2 years old: ask a doctor.” There is a problem even after parents then ask a doctor or pharmacist for the correct dose. Dosing charts used by doctors and pharmacists only estimate the dose based on adult doses and adjust it based on the child’s weight. This may not be accurate. The FDA does not have dosing guidelines for OTC cough and cold preparations for children under 2 years old. Studies have not proven if these proposed doses are safe or effective.

Which product should I use?
There are more than 100 cough and cold products available. Combination products contain more than one drug, so they can treat several symptoms at once. This is viewed to be cheaper and more convenient by consumers. For example, a combination product may treat a fever, cough, congestion, and runny nose. This may be suitable if all of the symptoms are present. If a person does not have all of the symptoms, they are taking drugs that they do not need. It is safer to treat only symptoms that are present. Single ingredient medications are the better option.

Combination products may have different names but could contain some of the same ingredients:

It is easy to see in the chart above that a child getting two different combination products containing similar medicines could be getting double the recommended amount of a certain drug.

Accidental Overdoses
Children can accidentally be given too much medicine.  It can be very dangerous if a child is given more medicine than is recommended. Besides parents, children may be given medicines by other family members, grandparents as well as babysitters. A child could be given too much of a drug if more than one person gives a child the same dose. For example, a mother could give the child medicine in the morning before a babysitter comes over. The babysitter could be giving medicine to the child throughout the day without knowing that the mother had already given the child the medicine. The father could give even more medicine after the babysitter leaves. The child could get much more medicine this way.

It is important to make sure that everyone knows what medicine the child is taking and when they have taken it. Parents should write down what medication was given and when it was given. This information should be given to all those taking care of the child. It could also be posted on the refrigerator. 

Always read the label
It is important to look at the back of the package at the “Drug Facts” and read and understand the active drugs that are in the cold medicine before giving it to your child.

Common drugs found in OTC cough and cold medicines

Drug Class	OTC Drugs	Use	Information
Antihistamine	diphenhydramine brompheniramine chlorpheniramine	runny nose itchy eyes sneezing	can cause drowsiness can cause excitement in some Some side effects include: dry mouth, dizziness, fast heart rate, and hallucinations
Cough suppressants or antitussives	dextromethorphan codeine	reduce coughing	codeine can decrease pain, but can be addictive dextromethorphan overdose could result in hyperexitability to lethargy and even coma not recommended for young children coughing is helpful by removing mucus from lungs.
Expectorant	guaifenesin	helps to cough up mucus, thins mucus	generally safe may not work in children drinking water also thins mucus
Analgesics or antipyretics	acetaminophen ibuprofen	reduce fever, aches and pains	generally safe won’t shorten a cold

Some products contain both a cough suppressant and an expectorant. For example, Robitussin® Infant Cough DM contains both dextromethorphan and guaifenesin. Guaifenesin makes coughing more productive. But, dextromethorphan decreases coughing. This could lead to increased mucus remaining in the lungs. The two drugs are working against each other. This combination should generally be avoided.

Do I need to use cough and cold medicine?
Colds should go away without taking cold medicines. Cold medicines are for treating symptoms. They do not shorten the length of the cold. The safest option may be to not use cold medicine at all.

How to treat a cold in young children without cold/cough medicine:

• Use saline nasal spray or drops to dry runny noses
• Use rubber suction bulb to clear nose of mucus
• Use a cool-mist humidifier to help coughing and congestion
• Drink plenty of water or thin liquids to thin mucus
• Give acetaminophen or ibuprofen for fever or aches

Keeping children safe
The way that colds and coughs are treated in young children may change significantly. Next month, the FDA will discuss the use of cough and cold medicines in children. The FDA will be looking at reports of overdoses. They will also address the effectiveness of cold medicines in children.  Until then, parents should:

• Follow the directions on the product label and not give more medicine than recommended
• Consult with their child’s doctor or a pharmacist before giving medicine to young children
• Use oral syringes, droppers or medicine spoons. They are more accurate than kitchen spoons for measuring
• Keep track of what medicines are given to the child and when they were given.

All parents should be aware that OTC products can be dangerous if not used properly. A cold will go away without taking OTC medicines. Parents should think twice about giving their children cough and cold products because they may be doing more harm than good. 

© 2007 Consumer Health Information Corporation. All rights reserved.