Major producers of over-the-counter cough and cold medicines announced today that they were voluntarily withdrawing their products from the market for fear that they could be misused by parents. The voluntary withdrawal affects only products labeled for use in infants and children under 2 years of age.

The action comes two weeks after reviewers within the Food and Drug Administration (FDA) urged the agency to consider an outright ban of over-the-counter cough and cold products for children under the age of 6 years—a move previously recommended by the industry’s own trade association, the Consumer Healthcare Products Association (CHPA).

A Non-prescription Drugs Advisory Committee will meet October 18-19 to further examine the safety and effectiveness of cough and cold medicines in children, and offer recommendations to the FDA.

There are roughly 800 over-the-counter pediatric cough and cold medicines. The CHPA maintain that the medicines are safe and effective when used as directed.

U.S. Food and Drug Administration reviewers have said that from 1969 through 2006 the agency received 54 reports of deaths with decongestants and 69 with antihistamines. Most were in children younger than 2 years. Overdose and drug toxicity were commonly reported in those cases, they said. Many of these children died after their parents mistakenly gave them too much medicine, either because they did not realize that products from two different manufacturers contained the same ingredient, or the parents measured doses incorrectly. But there are growing reports that even children given recommended quantities of the medicines may be at risk.

The Poison Control Center of the Children’s Hospital of Philadelphia recently reported on four cases of prolonged hallucinations in children as old as 6 years who were given recommended doses of the medicines. With almost no evidence that they are effective and growing worries that they may be unsafe, a group of prominent pediatricians petitioned the agency earlier this year to consider banning the drugs’ use in young children.

Among the products being withdrawn are Dimetapp Decongestant Infant Drops, Little Colds Decongestant Plus Cough, Pediacare Infant Drops Decongestant, Robitussin Infant Cough DM Drops, Triaminic Infant and Toddler Thin Strips Decongestant, and Tylenol Concentrated Infant Drops Plus Cold and Cough. A complete listing can be found on the CHPA website.
Reports of child morbidity and mortality associated with the use of these products appears to be the result of giving too much of these medicines to children. An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if the medicine is given too often, or if more than one cough and cold medicine containing the same active ingredient is used. To avoid overdoses, parents must carefully follow the directions for use that appear on the package label.

What should parents know about using cough and cold products in children?

• Do NOT use cough and cold products in children under 2 years of age UNLESS you are instructed to do so by your child’s healthcare provider and are given clear instructions regarding how much and how often to give the medicine.

• Do not give children medicine that clearly states on the package that it is intended for adults. Use only medicines labeled for use in babies, infants or children (sometimes called “pediatric” use).

• Cough and cold medicines come in many different strengths. If you are unsure about which product is safe for your child, ask your child’s healthcare provider.

• If other medicines (over-the-counter or prescription) are being given to your child, ask your child’s healthcare provider if their combined use is safe.

• Read all of the information in the Drug Facts box on the package label so that you know the active ingredients and the warnings.

• Follow the directions in the Drug Facts box. Do not give your child medicine more often or in greater amounts than is clearly stated on the package.

• Too much medicine can lead to serious and life-threatening side effects, particularly in children 2 years of age and younger.

• For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with the medicine. It should be clearly marked so that the recommended dose is given. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.

• If a measuring device is not included with the product, parents should purchase one at the pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the Drug Facts box on the package label, or is recommended by the child’s health care provider.

• If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine. Consult your child’s healthcare provider if you have questions or are confused.

• Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.

If a child’s condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.