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Page: << Prev | 1 | 2 | 3 | Next >> 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.
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"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."
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