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Caution Urged With Kids' Cold Medicine

Media Contact: Mary Colliver 

LEXINGTON, Ky. (Jan. 12, 2010) −In recent years, the Food and Drug Administration has reviewed the safety and effectiveness of over-the-counter (OTC) cough and cold medicine for children. The FDA warned parents to not give children age 2 or younger OTC cough and cold medicine unless specifically instructed to do so. The American Academy of Pediatrics states that OTC cough and cold medicines do not work for children younger than 6 years and in some cases may pose a health risk.

This has been a concern to Dr. Rhya Strifling, a pediatrician at Kentucky Children's Hospital, and an assistant professor of pediatrics in the University of Kentucky College of Medicine.

"The FDA advisory was issued for children because cough and cold medicines affect children differently than adults and have the potential for serious side effects," Strifling said. "There have not been enough studies done with children to show if these medications are even effective,"

These medications can cause problems in children, because their bodies do not handle them in the same way as adults' bodies do.

"Drugs have the potential to build up in children because they may not have the ability to clear the medication as quickly," Strifling said. "I never recommend giving cough and cold medicine to a child under 2 years and rarely in children under 6 years of age.”

The FDA began review of children’s cough and cold medicines after questions were raised about the safety of these products for children, particularly in children under the age of 2. It is still unclear whether the benefits of these medications outweigh any potential risks. Some research finds that medications are safe to use when the package indications are followed, while other research suggests cough and cold medicines are not effective in children and should not be used.

What did the FDA advisory include? 

The FDA public health advisory issued in August recommends the following to parents using OTC cough and cold medicine in children:

  • Do not use cough and cold products in children under 2 years of age unless given specific directions to do so by a health-care provider.
  • Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).
  • Cough and cold medicines come in several strengths. If you are unsure about the right product for your child, ask a health-care provider.
  • If other medicines (OTC or prescription) are being given to a child, the child’s health-care provider should review and approve their combined use.
  • Read all of the information and follow directions in the “Drug Facts” box on the package label so that you know the active ingredients and the warnings.

"Parents should be aware that there have not been enough studies done in children to show if these medicines are effective or safe,” said Strifling. “The dosage for children’s medicine is based on adult clinical trials.” As a result, dosage is based on weight for children, making it difficult to have a standardized dosage. For example, not all 2-year-olds are the same size and weight."

Strifling says that it is best not to use OTC cough and cold medicines if your child is under the age of 6 years, and especially under the age of 2 years. But if you do, it is important to talk with your doctor about correct dosage. Even though it is over-the-counter medication, adverse effects can occur if dosage instructions are not followed.

Risks and benefits 

The American Academy of Pediatrics recommends never giving cough and cold medication to children under age 6 years, and especially under age 2 years.

"Once children are age 6 years or older, medication is reasonable in some instances but not in all," said Strifling. "Some medicines that suppress a child’s cough, prevent the child from clearing the congestion and mucous from their lungs. Other medicines might make the mucous thicker and harder for younger children to get rid of. Most colds will get better with time without medication.”

Home remedies for a cold 

Strifling says there are some great options for parents who want to make their children more comfortable during a cold but wish to avoid cough and cold medicine. If your child’s cold symptoms are not interfering with daily activity or sleep, try some of the following methods:

  • Encourage lots of liquids—water, juice, milk.
  • A vaporizer/humidifier or steam to reduce congestion (clean humidifier every day).
  • Nasal suction to remove mucus.
  • Salt-water nose drops (1/4 teaspoon salt in 1 cup water) before eating or sleeping.
  • Elevation of the head of the bed to relieve nighttime cough.
  • A teaspoon of honey to relieve cough (only if child is 1 year or older).

Reading the package label

It is important to read the package label carefully and know what the active drugs are in each medication. Learn the generic name as well as the brand name so you can recognize what active ingredients are in a brand name medication. For instance, acetaminophen is the generic name for Tylenol; it can be beneficial to treat aches, pains and a fever. There is acetaminophen in some multi-symptom medications such as Nyquil, but typically not enough to bring down a fever.

"You don’t want to give your child both Tylenol and Nyquil because they both contain acetaminophen," said Strifling. "I typically recommend patients avoid the multi-medication drugs. It is best to treat the child’s specific symptoms. For example, if your child is 6 years or older and has nasal congestion but no cough, then a decongestant would be better than a multi-symptom medication. There is more risk of overdosing your child with certain ingredients if you use a multi-symptom medication.

"Remember, you cannot cure a cold with antibiotics or cough and cold medicine. Colds are only cured by time. The most important thing is to try some of the methods listed above to help make sure that your child is comfortable and well hydrated during a cold." 

Page last updated: 11/20/2013 2:29:30 PM