Q&A: Infant Cold Medications in the News?

The uproar is scary to us, too! This basic breakdown explains the major issues.

And — don’t forget to check out our non-medicinal cough and cold remedies.

The Concern

According to an FDA public health advisory released last Friday, cough and cold medications — even those marketed specifically towards infants and toddlers — have no proven effectiveness in young children, and can actually cause severe harm.

The FDA started the review last March, after a group of doctors and public health officials filed a petition questioning the safety of such medications.

The Statistics

Between 1969 and 2006, 54 deaths related to decongestant usage and 69 related to antihistamines have been reported in children, mostly those under age two.

According to a CDC report, 1,500 toddlers and babies have been in emergency rooms over the last two years because of such medications.

In 1990, Americans spent almost 2 billion on infant and children cough medications.

Almost 30 different cough and cold medications marketed specifically for children can be found in the average drugstore.

How Could This Happen?

Decongestants and antihistamines have actually never been tested in children. However, the FDA has allowed them to be marketed to young children for years, based on the — now known to be faulty — assumption that children’s bodies are simply small versions of adults’.

The Dangerous Ingredients

In decongestants: Pseudoephedrine, phenylephrine and ephedrine.

In antihistamines: Diphenhydramine, brompheniramine and chlorpheniramine.

The FDA’s Stance

Medication bottles currently advise parents to consult a physician about decongestant usage in children under two and antihistamine usage in children under six.

The FDA wants to replace this label with a recommendation against any use of the medications in those age groups, due to a “lack of evidence of efficacy and safety concerns.”

Also, the FDA also wants all products marketed specifically towards young children be removed from the market.

The Drug-Maker’s Stance

The Consumer’s Healthcare Products Association — an industry trade group which in the past has defended the safety of children’s cough and cold medications — also released a statement last Friday agreeing with the FDA. The group now recommends mandatory warning labels advising such medications should never be given to children under age two.

What’s Next?

Always discuss any medication use with your pediatrician. Make sure to go over appropriate amount and frequency of dosage, the specific medication being administered, and the interaction between medications being given simultaneously.

Please note: The Bump and the materials and information it contains are not intended to, and do not constitute, medical or other health advice or diagnosis and should not be used as such. You should always consult with a qualified physician or health professional about your specific circumstances.