Half of parents misinterpret OTC cough and cold medication labels

Nearly nine in 10 parents think at first glance that the drugs are appropriate for infants, despite FDA warnings.

By Kevin B. O’Reilly — Posted July 24, 2009

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The Food and Drug Administration in January 2008 advised parents to avoid giving over-the-counter cough and cold medicines to children younger than 2 because potential overdosing risks outweigh the symptom-relieving benefits. But a new study found that many parents are confused by medication labels that say "infant" or display child-friendly graphics such as pictures of teddy bears.

Looking at the front of the package, 86% of 182 caregivers surveyed thought the drugs were appropriate for infants, according to the study, published in the June issue of Pediatrics (link). When asked to review the entire package, 51% thought it would be OK to give the medicine to a 13-month-old child with cold symptoms despite a label warning that a doctor should be consulted before using the drug in a child younger than 2.

More than 80% of caregivers -- most of whom were mothers -- already were using cough and cold medications for their infants, the study said. The study's authors said the FDA should "ban misleading graphics on all OTC-product packaging" to "help prevent significant harm to children."

They cautioned that, on the basis of the study's results about how parents interpret labels, "a single warning statement or revision of dosing guidelines will not adequately guard against inappropriate medication use by parents of young children."

Medication safety experts said the focus on labeling, while important, might distract from more effective harm-prevention strategies.

"I am not sure how much changing the label will have an impact," said Matthew Grissinger, director of error reporting programs at the Institute for Safe Medication Practices in Horsham, Pa. "At the end of the day, there needs to be more help than what's on the label. We need more involvement by health care practitioners."

Grissinger, who was not involved in the Pediatrics study, said "relying on just changing the label is a low-leverage strategy. It requires you to do the reading, understand what you're reading and ask questions. We need to put other things in place in reality."

Grissinger advised that physicians seeing parents with infants warn against cough and cold medications, and urged pharmacists to make time to counsel parents. He suggested that drug stores place child cold medications near the pharmacy counter to make it easier for parents to ask questions.

"We need to get out the word that parents don't need this stuff in the first place," he said.

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