Parents Ignore FDA Warnings about Cough and Cold Meds

Despite the fact that the FDA formally recommended that over-the-counter cough and cold medicines are not given to children under the age of two, a new survey shows that the majority of parents still administer the drugs to youngsters.

OTC cough and cold products have been linked to poisoning or death in hundreds of children ages two and younger, and studies have shown that these medications do little to control symptoms. As a result, in 2008, the FDA formally recommended that the products not be given to this population.

According to the C.S. Mott Children's Hospital National Poll on Children's Health, 61% of parents of children age two and younger gave their kids OTC cough and cold medicine within the last 12 months. The poll also shows that more than half of parents report that their child's doctor says OTC cough and cold medications are safe for children under two; half of their physicians said they are effective.

"FDA warnings about OTC cough and cold medicines prompted a voluntary recall of products marketed for children younger than two years," said Matthew Davis, MD, of University of Michigan Medical School, in a press release. "We wanted to see how well parents and physicians were adopting those recommendations. Unfortunately, this latest poll indicates that the FDA warnings have gone unheeded by the majority of parents, and surprisingly, many physicians."

In January 2011, the C.S. Mott Children's Hospital poll asked parents across the US with children between the ages of six months and two years about their use of OTC cough and cold medicines.

Findings were as follows:

• While about 61% of parents with children age two and under have given their children OTC cough and cold medicines within the last 12 months, use of such medicines differs by race/ethnicity-higher among black (80%) and Hispanic (69%) parents than among white parents (57%).
• Use also differs by income-highest (80%) in families with annual income of less than $30,000 and lowest (41%) in families with income of $100,000 or more.
• Use of OTC medications is not different if the parent had older children at home.
• When deciding whether to use an OTC medicine, two-thirds of parents report wanting their child to be able to sleep better or to be more comfortable during the day as "very important" reasons for using the medications.
• 56% of parents say having their child's health care provider recommend the medicine was very important.

"There are challenges to informing parents about this topic," said Davis, the poll’s director. "The FDA warning is specific to young children, age two and under—but parents of those kids may not have heard the warnings issued more than two years ago. Each year a 'new generation' of parents must be educated about a wide variety of health care issues for their children. Physicians are a valuable source of information for parents about this issue, but it appears that physicians are not heeding FDA warnings about OTC cough and cold medicines either. Kids will be safer when parents and doctors are all on the same page in limiting these medicines to older children."

Further study is needed to verify that child health care providers understand FDA warnings about OTC cough and cold medicines, and to ensure that health care providers are giving parents clear and consistent messages about these medicines' safety and effectiveness, according to the authors.