May 1, 2013
OTC Cold Remedies Given to Children Too Young
to Use Them

Ann Arbor, MI—When adults purchase OTC cough and cold medications for children, pharmacists might want to make sure that the products’ age limitations are fully understood.

Many parents unknowingly administer the OTC products to children not old enough to safely use them.

That’s according to a new University of Michigan poll, which finds that more than 40% of parents reported giving cough medicine or multisymptom cough and cold medicine to children under age 4, even though product labels recommend against it.

The C.S. Mott Children’s Hospital National Poll on Children’s Health also found that 25% of parents gave decongestants to their young children. The FDA says that children under 2 years old should never be given cough and cold products containing the decongestants ephedrine, pseudoephedrine, or phenylephrine, and the antihistamines diphenhydramine, brompheniramine, or chlorpheniramine without consulting a health care provider.

Concerned about lack of effectiveness and the risk of serious side effects, the FDA first issued an advisory in 2008 that OTC cough and cold products not be used in infants and children under age 2.

In response to the FDA, manufacturers of those products changed their labels to state that the medicines should not be used for children under 4 years old.

“These products don’t reduce the time the infection will last and misuse could lead to serious harm,” said Matthew M. Davis, MD, MAPP, director of the C.S. Mott Children’s Hospital National Poll on Children’s Health. “What can be confusing, however, is that often these products are labeled prominently as ‘children’s’ medications. The details are often on the back of the box, in small print. That’s where parents and caregivers can find instructions that they should not be used in children under 4 years old.”

Side effects from use of cough and cold medicines in young children could include allergic reactions, increased or uneven heart rate, drowsiness or sleeplessness, slow and shallow breathing, confusion or hallucinations, convulsions, nausea, and constipation.

The nationally representative household survey, conducted exclusively by GfK Custom Research, LLC (GfK), for C.S. Mott Children’s Hospital, was administered in January 2013 to a randomly selected, stratified group of parents with a child age 0-3 (n = 498) from a Web-enabled panel that closely resembles the U.S. population The sample was subsequently weighted to reflect population figures from the Census Bureau. The survey completion rate was 57% among the panel members contacted to participate. The margin of error is ± 8 to 11 percentage points and higher among subgroups.

Misuse of the products in young children was across-the-board, according to the poll, with no differences by gender, race, ethnicity, or household income.

“Products like these may work for adults, and parents think it could help their children as well. But what's good for adults is not always good for children,” Davis noted. “Because young children often suffer from cold-like symptoms, more research is needed to test the safety and efficacy of these cough and cold medicines in our littlest patients.”

If pharmacists are asked for alternatives to the products to treat their young child’s cold symptoms, they might offer these suggestions from the FDA:

• A cool mist humidifier to help nasal passages shrink and allow easier breathing (warm mist humidifiers can cause nasal passages to swell and make breathing more difficult);
• Saline nose drops or spray to keep nasal passages moist and help avoid stuffiness;
• Nasal suctioning with a bulb syringe either with or without saline nose drops, especially for infants less than a year old;
• Acetaminophen or ibuprofen in compliance with the product’s usage instructions to reduce fever, aches, and pains.
• Providing plenty of liquids to help the child stay well hydrated.

U.S. Pharmacist Social Connect