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
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
- If other medicines (OTC or prescription) are being given to a
child, the child’s health-care provider should review and approve their
- 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
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
"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
- 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
"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."