The labeling on children's over-the-counter cold medicines can be confusing to parents, a new study has found.
Simpler language and clearer graphics are needed to guide the selection and safe use of the medications, said the study's lead researcher, Dr. Russell Rothman, an assistant professor of internal medicine and pediatrics at Vanderbilt University Medical Center.
"The age indications of over-the-counter pediatric cold and cough products are difficult for caregivers to understand," he said. "These misinterpretations may pose significant hazards to child safety."
In 2007, the U.S. Food and Drug Administration advised against the use of over-the-counter cough and cold medications in children younger than 2, and the drug makers voluntarily removed many of the products from the market. Labeling was changed on others.
However, because products intended for kids 4 and older remain on the market, Rothman and his research team decided to test parents' understanding of the information conveyed on labels.
They asked 182 parents to read labels of four over-the-counter cold and cough medicines. The labels were all from products that later were pulled from the market, because they had been labeled for "infant" use. The labels advised consulting a physician if the product was to be used in children 2 years old.
About 86 percent of the time, parents thought that the medicines could be given to children younger than 2, the study found.
In addition, dosing instructions were often not looked at or understood. More than half the time, the parents said they would give these drugs to a 13-month-old child with cold symptoms, even though the label said to consult a physician first.
The parents said they were influenced by pictures of infants, teddy bears and droppers, and the word "infant" on labels. Those with poorer math skills were more likely to give inappropriate answers, the researchers found.
The report is in the June issue of Pediatrics.
"Instructions on over-the-counter cough and cold medicines can be difficult to understand, and this can potentially lead to misuse and threats to child safety," Rothman said. "Labeling needs further improvements to aid parental understanding."
Though some manufacturers have made recent changes to the labels of over-the-counter (OTC) medications, "the changes made vary from product to product, and it is not uniform," Rothman said.
"Manufacturers and the FDA should continue to work together to further improve current OTC labels," he said. "This includes removing misleading graphics, using more uniform, plain language, improving the display of quantitative information and simplifying the Drug Facts Panel component of the label. Any warnings about use -- related to age and other factors -- need to be more prominently displayed using simple, uniform language with large, bold print that is easy to read and identify on the package."
Beyond labeling, however, Rothman said that whether the products work and should be used at all in children is an ongoing debate.
He said that there is limited data to support the efficacy of the medicines in children younger than 6. "Parents should be cautious about using over-the-counter cold and cough medicines, particularly medicines that contain combinations of products," Rothman said. "They should read packaging carefully and discuss with their doctor or other health-care providers before use."
And the study, he said, raises important concerns about parental understanding of all over-the-counter products and potential threats to the safety of children of all ages, not just those younger than 2.
"We applaud the pharmaceutical industry's recent announcement to add warnings on these products for children less than 4 years old," Rothman said. "However, if over-the-counter cold and cough products marketed for children are to remain on the market, significant changes are necessary to make product packaging and labeling more clearly understandable by all caregivers. A single warning statement is unlikely to be sufficient."
He said the researchers hope that the study's findings "will be of use to the FDA as it continues to deliberate how better to inform the public about the appropriateness of over-the-counter medications."
Dr. Michael G. Spigarelli, an assistant professor of pediatrics and internal medicine at Cincinnati Children's Hospital Medical Center, said that the labels now used on these medicines are clearer.
"I don't disagree with the findings, but I think they are out of date," Spigarelli said. "I don't think they used the current language." The new packages, for example, no longer say, "pediatrician recommended" and "consult your doctor," he said.
But he agrees that drug labeling can be confusing. "It's part marketing and part science, and I don't know that they interact very well together," he said.
Labels need to serve the public and tell the truth about the medication -- not merely protect manufacturers from liability, Spigarelli said.
"The labeling should be readable by the public, and it should be honest," Spigarelli said. "The problem is, as soon as you add the word 'honest,' you start getting legal, which makes it more complicated."
More information
The U.S. Food and Drug Administration has more on cold medicines for children.
Source: Health News
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